A Phase 1/2 interventional study of [68Ga]-PSMA-R2 in Prostate Cancer Metastatic, sponsored by Advanced Accelerator Applications. Completed at 5 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Advanced Accelerator Applications (part of Novartis) · Phase 1/2, Interventional, and Diagnostic
This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
This study consisted of 2 parts.
This study was comprised of 4 clinical visits and conducted in 3 study periods: screening, administration/imaging, and safety follow-up period.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Advanced Accelerator Applications is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
First submitted after Advanced Accelerator Applications became part of Novartis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
confirmed adenocarcinoma of the prostate, defined as follows:
Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or lesions.
OR
Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
Drug: [68Ga]-PSMA-R2
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
Drug: [68Ga]-PSMA-R2
All eligible participants received recommended dose of \[68Ga\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq\].
Drug: [68Ga]-PSMA-R2
radio-labelled PSMA ligand
Number of Participants With Treatment Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time frame: dosing through 28 days post-dose
Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)
Phase I: Urinary Excretion of [68Ga]-PSMA-R2
Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.
Time frame: 0 to 6 hours post-dose
Phase I: Half-life of 68Ga-PSMA-R2 in Blood
Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\^1/2) for the analyte in blood was summarized with descriptive statistics.
Time frame: 0 to 6 hours post-dose
Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)
Phase I: Residence Times in Normal Organs
Residence times of radiation in normal organs were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Phase I: Absorbed Dose of 68Ga-PSMA-R2
Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Phase I: Whole-body Dose of 68Ga-PSMA-R2
The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Phase I: Effective Dose of 68Ga-PSMA-R2
The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients
The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows: * Positive percent agreement: a/(a+c) × 100 * Negative percent agreement: d/(b+d) × 100 * Overall percent agreement: (a+d)/(a+b+c+d) × 100 Where: * a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan * b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan * c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan * d = number of subjects with no lesions detected by conventional scan or PET scan.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)
Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)
The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.
Time frame: 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection)
This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)
| Milestone | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| Started | 6 | 12 | 12 |
| Completed | 5 | 12 | 12 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Family issue (child custody) | 1 | 0 | 0 |
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
| Participants | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| Treatment-Emergent Adverse Events (TEAEs) | 1 | 4 | 2 |
| Serious TEAEs | 0 | 1 | 0 |
| Deaths Due to AEs | 0 | 0 | 0 |
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
| mSv/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Brain@20-30 minutes post-injection | 0.002196 ± 0.0009359 |
| Brain@1 hour post-injection | 0.001913 ± 0.0003011 |
| Brain@2 hours post-injection | 0.001310 ± 0.0005902 |
| Brain@3-4 hours post-injection | 0.001279 ± 0.0007786 |
| Heart Wall@20-30 minutes post-injection | 0.009010 ± 0.0014472 |
| Heart Wall@1 hour post-injection | 0.006371 ± 0.0012260 |
| Heart Wall@2 hours post-injection | 0.004330 ± 0.0014781 |
| Heart Wall@3-4 hours post-injection | 0.003209 ± 0.0014961 |
| Kidney@20-30 minutes post-injection | 0.033219 ± 0.0140235 |
| Kidney@1 hour post-injection | 0.022069 ± 0.0090106 |
| Kidney@2 hours post-injection | 0.018424 ± 0.0068331 |
| Kidney@3-4 hours post-injection | 0.015772 ± 0.0069341 |
| Lacrimal Gland@20-30 minutes post-injection | 0.000016 ± 0.0000023 |
| Lacrimal Gland@1 hour post-injection | 0.000016 ± 0.0000051 |
| Lacrimal Gland@2 hours post-injection | 0.000015 ± 0.0000045 |
| Lacrimal Gland@3-4 hours post-injection | 0.000014 ± 0.0000074 |
| Liver@20-30 minutes post-injection | 0.040546 ± 0.0098781 |
| Liver@1 hour post-injection | 0.030958 ± 0.0073605 |
| Liver@2 hours post-injection | 0.023145 ± 0.0083627 |
| Liver@3-4 hours post-injection | 0.018128 ± 0.0081345 |
| Lungs@20-30 minutes post-injection | 0.010066 ± 0.0017280 |
| Lungs@1 hour post-injection | 0.007535 ± 0.0013048 |
| Lungs@2 hours post-injection | 0.005023 ± 0.0015987 |
| Lungs@3-4 hours post-injection | 0.003601 ± 0.0016623 |
| Salivary Gland@20-30 minutes post-injection | 0.002001 ± 0.0004118 |
| Salivary Gland@1 hour post-injection | 0.001585 ± 0.0004877 |
| Salivary Gland@2 hours post-injection | 0.001282 ± 0.0006661 |
| Salivary Gland@3-4 hours post-injection | 0.001032 ± 0.0005455 |
| Spleen@20-30 minutes post-injection | 0.003712 ± 0.0010597 |
| Spleen@1 hour post-injection | 0.002645 ± 0.0008966 |
| Spleen@2 hours post-injection | 0.001724 ± 0.0007601 |
| Spleen@3-4 hours post-injection | 0.001264 ± 0.0006056 |
| Thyroid@20-30 minutes post-injection | 0.000378 ± NA |
| Thyroid@1 hour post-injection | 0.000266 ± NA |
| Thyroid@2 hours post-injection | 0.000201 ± NA |
| Thyroid@3-4 hours post-injection | 0.000128 ± NA |
Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.
| mL/hr | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Phase I: Urinary Excretion of [68Ga]-PSMA-R2 | 5870 ± 1820 |
Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\^1/2) for the analyte in blood was summarized with descriptive statistics.
| Hour | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Phase I: Half-life of 68Ga-PSMA-R2 in Blood | 2.83 ± 0.868 |
PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.
| mSv/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Brain@20-30 minutes post-injection | 0.001686 ± 0.0007242 |
| Brain@1 hour post-injection | 0.001046 ± 0.0000814 |
| Brain@2 hours post-injection | 0.000423 ± 0.0001630 |
| Brain@3-4 hours post-injection | 0.000222 ± 0.0000924 |
| Heart Wall@20-30 minutes post-injection | 0.006914 ± 0.0011156 |
| Heart Wall@1 hour post-injection | 0.003484 ± 0.0004766 |
| Heart Wall@2 hours post-injection | 0.001332 ± 0.0002056 |
| Heart Wall@3-4 hours post-injection | 0.000542 ± 0.0001255 |
| Kidney@20-30 minutes post-injection | 0.025506 ± 0.0107777 |
| Kidney@1 hour post-injection | 0.012059 ± 0.0043426 |
| Kidney@2 hours post-injection | 0.005825 ± 0.0015596 |
| Kidney@3-4 hours post-injection | 0.002766 ± 0.0006581 |
| Lacrimal Gland@20-30 minutes post-injection | 0.000012 ± 0.0000019 |
| Lacrimal Gland@1 hour post-injection | 0.000009 ± 0.0000022 |
| Lacrimal Gland@2 hours post-injection | 0.000005 ± 0.0000011 |
| Lacrimal Gland@3-4 hours post-injection | 0.000002 ± 0.0000008 |
| Liver@20-30 minutes post-injection | 0.031128 ± 0.0076342 |
| Liver@1 hour post-injection | 0.016949 ± 0.0032692 |
| Liver@2 hours post-injection | 0.007172 ± 0.0014994 |
| Liver@3-4 hours post-injection | 0.003087 ± 0.0006828 |
| Lungs@20-30 minutes post-injection | 0.007729 ± 0.0013599 |
| Lungs@1 hour post-injection | 0.004149 ± 0.0006660 |
| Lungs@2 hours post-injection | 0.001573 ± 0.0002652 |
| Lungs@3-4 hours post-injection | 0.000631 ± 0.0001601 |
| Salivary Gland@20-30 minutes post-injection | 0.001536 ± 0.0003192 |
| Salivary Gland@1 hour post-injection | 0.000859 ± 0.0002093 |
| Salivary Gland@2 hours post-injection | 0.000386 ± 0.0001469 |
| Salivary Gland@3-4 hours post-injection | 0.000173 ± 0.0000550 |
| Spleen@20-30 minutes post-injection | 0.002849 ± 0.0008140 |
| Spleen@1 hour post-injection | 0.001444 ± 0.0004213 |
| Spleen@2 hours post-injection | 0.000536 ± 0.0001640 |
| Spleen@3-4 hours post-injection | 0.000217 ± 0.0000567 |
| Thyroid@20-30 minutes post-injection | 0.000289 ± NA |
| Thyroid@1 hour post-injection | 0.000136 ± NA |
| Thyroid@2 hours post-injection | 0.000057 ± NA |
| Thyroid@3-4 hours post-injection | 0.000020 ± NA |
Residence times of radiation in normal organs were summarized with descriptive statistics.
| MBq-hr/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Brain | 0.002895 ± 0.0009849 |
| Heart | 0.010459 ± 0.0014152 |
| Kidney | 0.039360 ± 0.0133500 |
| Lacrimal Gland | 0.000027 ± 0.0000052 |
| Liver | 0.050735 ± 0.0103951 |
| Lungs | 0.012084 ± 0.0019321 |
| Salivary Gland | 0.002594 ± 0.0006622 |
| Spleen | 0.004291 ± 0.0012416 |
| Thyroid | 0.000424 ± NA |
| Urinary Bladder | 0.092947 ± 0.0453608 |
| Remainder | 1.417135 ± 0.0582923 |
Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.
| mGy/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Brain | 0.002563 ± 0.000336 |
| Heart | 0.018417 ± 0.0020094 |
| Kidney | 0.060683 ± 0.0190588 |
| Lacrimal Gland | 0.008065 ± 0.0015741 |
| Liver | 0.017417 ± 0.0029976 |
| Lungs | 0.007967 ± 0.0007718 |
| Red Marrow | 0.010700 ± 0.0002280 |
| Salivary Gland | 0.015600 ± 0.0032012 |
| Spleen | 0.017333 ± 0.0037109 |
| Urinary Bladder | 0.120317 ± 0.0517023 |
The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
| mGy/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Phase I: Whole-body Dose of 68Ga-PSMA-R2 | 0.013800 ± 0.0000632 |
The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.
| mSv/MBq | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) |
|---|---|
| Phase I: Effective Dose of 68Ga-PSMA-R2 | 0.014583 ± 0.0019343 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
| Standard Uptake Value (SUV) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): SUVmax (lesion) | 4.493 ± 1.4060 | 4.421 ± 1.4512 | 6.725 ± 5.5327 |
| PET (1hr): SUVmean (background) | 0.980 ± 0.0283 | 0.643 ± 0.2318 | 0.750 ± 0.3002 |
| PET (2hr): SUVmax (lesion) | 3.767 ± 1.1493 | 5.098 ± 1.8597 | 6.846 ± 4.7745 |
| PET (2hr): SUVmean (background) | 0.630 ± 0.3145 | 0.651 ± 0.2817 | 0.550 ± 0.1948 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
| Ratio | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): TBR | 4.520 ± 1.3558 | 7.464 ± 3.0364 | 11.141 ± 10.6283 |
| PET (2hr): TBR | 5.694 ± 1.7104 | 7.780 ± 3.6034 | 12.588 ± 9.1146 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
| Standard Uptake Value (SUV) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): SUVmax (lesion) | — | — | 7.087 ± 4.9133 |
| PET (1hr): SUVmean (background) | — | — | 0.689 ± 0.1955 |
| PET (2hr): SUVmax (lesion) | — | — | 7.647 ± 5.3409 |
| PET (2hr): SUVmean (background) | — | — | 0.541 ± 0.2234 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
| Ratio | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): TBR | — | — | 11.573 ± 10.2632 |
| PET (2hr): TBR | — | — | 14.880 ± 10.1991 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.
| Standard Uptake Value (SUV) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): SUVmax (lesion) | 4.493 ± 1.4060 | 4.421 ± 1.4512 | 6.578 ± 5.8224 |
| PET (1hr): SUVmean (background) | 0.980 ± 0.0283 | 0.643 ± 0.2318 | 0.723 ± 0.3020 |
| PET (2hr): SUVmax (lesion) | 3.767 ± 1.1493 | 5.098 ± 1.8597 | 6.566 ± 4.5956 |
| PET (2hr): SUVmean (background) | 0.630 ± 0.3145 | 0.651 ± 0.2817 | 0.581 ± 0.2119 |
Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.
| Ratio | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET (1hr): TBR | 4.520 ± 1.3558 | 7.464 ± 3.0364 | 10.965 ± 10.9067 |
| PET (2hr): TBR | 5.694 ± 1.7104 | 7.780 ± 3.6034 | 11.788 ± 8.6914 |
The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows: * Positive percent agreement: a/(a+c) × 100 * Negative percent agreement: d/(b+d) × 100 * Overall percent agreement: (a+d)/(a+b+c+d) × 100 Where: * a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan * b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan * c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan * d = number of subjects with no lesions detected by conventional scan or PET scan.
| Percent Agreement | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| PET(1hr): Positive percent agreement | 0.0 (NA to NA) | 0.0 (NA to NA) | 87.5 (47.35 to 99.68) |
| PET(1hr): Negative percent agreement | 66.7 (22.28 to 95.67) | 25.0 (5.49 to 57.19) | 0.0 (0.00 to 60.24) |
| PET(1hr): Overall percent agreement | 66.7 (22.28 to 95.67) | 25.0 (5.49 to 57.19) | 58.3 (27.67 to 84.83) |
| PET(2hr): Positive percent agreement | 0.0 (NA to NA) | 0.0 (NA to NA) | 87.5 (47.35 to 99.68) |
| PET(2hr): Negative percent agreement | 33.3 (4.33 to 77.72) | 25.0 (5.49 to 57.19) | 50.0 (6.76 to 93.24) |
| PET(2hr): Overall percent agreement | 33.3 (4.33 to 77.72) | 5.49 (5.49 to 57.19) | 75.0 (42.81 to 94.51) |
The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.
| Positive Lesion | Overall |
|---|---|
| PET (positive) | 22 |
| Conventional (postive) | 8 |
| Difference = PET(+) - Conventional(+) | 14 |
| PET(+) and detected by conventional scan | 7 |
| PET+/detected by CT:Bone,Cervical Spine | 1 |
| PET+/detected by CT:Bone,Lumbar Spine | 3 |
| PET+/detected by CT:Bone,Thoracic Spine | 3 |
| PET+/detected by CT:Pelvic Bone | 2 |
| PET+/detected by CT:Pelvis | 1 |
| PET+/detected by CT:Rib(s),L. | 1 |
| PET+/detected by CT:Rib(s),R. | 1 |
| PET(+) and not detected by conventional scan | 21 |
| PET+/undetected by CT:Abdominal Wall | 1 |
| PET+/undetected by CT:Bone,Lumbar Spine | 1 |
| PET+/undetected by CT:Bone,Other | 5 |
| PET+/undetected by CT:Bone,Thoracic Spine | 1 |
| PET+/undetected by CT:Lymph Node,Common Iliac | 9 |
| PET+/undetected by CT:Lymph Node,External | 1 |
| PET+/undetected by CT:Lymph Node,Inguinal,L. | 1 |
| PET+/undetected by CT:Lymph Node,Inguinal,R. | 1 |
| PET+/undetected by CT:Lymph Node,Para-Aortic | 6 |
| PET+/undetected by CT:Lymph Node,Retrocrural | 1 |
| PET+/undetected by CT:Lymph Node,Retroperitoneal | 2 |
| PET+/undetected by CT:Lymph Node,Supraclavicular,L | 1 |
| PET+/undetected by CT:Other,Extranodal | 3 |
| PET+/undetected by CT:Other,Nodal | 3 |
| PET+/undetected by CT:Pelvic Bone | 6 |
| PET+/undetected by CT:Rib(s),L. | 1 |
| PET+/undetected by CT:Rib(s),R. | 2 |
| PET+/undetected by CT:Urethra | 1 |
| Conventional (+) and not detected by PET scan | 7 |
| CT+/undetected by PET:Bone,Lumbar Spine | 2 |
| CT+/undetected by PET:Bone,Other | 2 |
| CT+/undetected by PET:Bone,Thoracic Spine | 5 |
| CT+/undetected by PET:Lymph Node,Pelvic | 1 |
| CT+/undetected by PET:Pelvic Bone | 6 |
| CT+/undetected by PET:Rib(s),L. | 2 |
| CT+/undetected by PET:Rib(s),R. | 1 |
| CT+/undetected by PET:Skull | 1 |
Collected over Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | 0/12 (0%) | 1/12 (8.3%) | 4/12 (33.3%) |
| Metastatic Prostate Cancer (mPCa) (Phase II) | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| IleusGastrointestinal disorders | 0/6 | 1/12 | 0/12 |
| Event | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) |
|---|---|---|---|
| FatigueGeneral disorders | 0/6 | 2/12 | 1/12 |
| LeukocytosisBlood and lymphatic system disorders | 1/6 | 0/12 | 0/12 |
| Influenza like illnessGeneral disorders | 0/6 | 1/12 | 0/12 |
| PyrexiaGeneral disorders | 0/6 | 1/12 | 0/12 |
| DysgeusiaNervous system disorders | 0/6 | 1/12 | 0/12 |
| HeadacheNervous system disorders | 0/6 | 0/12 | 1/12 |
| RashSkin and subcutaneous tissue disorders | 0/6 | 1/12 | 1/12 |
| DysuriaRenal and urinary disorders | 0/6 | 0/12 | 1/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/6 | 0/12 | 1/12 |
| Age, Continuous(Years) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Mean | 66.2 ± 7.91 | 69.1 ± 6.53 | 68.6 ± 10.00 | 68.3 ± 8.13 |
| Sex: Female, Male(Participants) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 6 | 12 | 12 | 30 |
| Race/Ethnicity, Customized(Participants) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Asian | 0 | 1 | 0 | 1 |
| White | 6 | 10 | 11 | 27 |
| Other | 0 | 1 | 1 | 2 |
| ECOG Performance Status(Participants) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Grade 0 | 6 | 9 | 6 | 21 |
| > = Grade 1 | 0 | 3 | 6 | 9 |
| Prostate-specific antigen (PSA) levels(ng/mL) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Mean | 1.68 ± 1.329 | 3.72 ± 6.461 | 38.56 ± 66.603 | 17.25 ± 44.861 |
| Time since first prostate cancer diagnosis(Months) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Mean | 79.2 ± 46.44 | 86.8 ± 78.07 | 96.1 ± 84.80 | 88.8 ± 73.41 |
| Time since first metastasis(Months) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Mean | 79.2 ± 46.44 | 86.8 ± 78.07 | 96.1 ± 84.80 | 88.8 ± 73.41 |
| Time since disease progression(Months) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Metastatic Prostate Cancer (mPCa) (Phase II) | Total |
|---|---|---|---|---|
| Mean | 34.7 ± 33.02 | 1.2 ± 1.55 | 0.8 ± 0.65 | 5.8 ± 16.01 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Studies of the drug tested here: Gallium-68
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