A Phase 2 interventional study of 68-Ga RM2. and 68-Ga PSMA11 in Prostate Cancer, sponsored by Andrei Iagaru. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Andrei Iagaru · Phase 2, Interventional, and Treatment
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer (PC)
Primary Objective:
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 4 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
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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.
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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).
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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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo either 68Ga RM2 PET/MRI followed within 2 weeks by 68Ga PMSA11 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Drug: 68-Ga RM2. · Drug: 68-Ga PSMA11 · Device: PET/MRI
Subjects will undergo 68Ga PMSA11 PET/MRI followed within 2 weeks by 68Ga RM2 PET/MRI. Two x intravenous (IV) 68Ga-RM2 PET/MRI with a 68Ga dosage of 140 mBq (3.8 mCi), +/- 20%, Two x intravenous (IV) 68Ga-PMSA11 PET/MRI with a 68Ga dosage of 111 to 259 mBq (3 to 7 mCi)
Drug: 68-Ga RM2. · Drug: 68-Ga PSMA11 · Device: PET/MRI
PET radiopharmaceutical
Also known as: BAY86 7548, 68Ga DOTA Bombesin
PET radiopharmaceutical
Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
PET/MR scanner by GE healthcare
Also known as: PET/MR scanner
Number of Participants With Successful Assessment of PET Based PC Lesions
Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans.
Time frame: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained
Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Day 1 (first scan) and 2 weeks (second scan) relative to baseline. First scan was approximately 2 months prior to HDR treatment
Progression Free Survival (PFS)
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.
Time frame: 24 months
| Milestone | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI |
|---|---|---|
| Started | 1 | 2 |
| Received first scan in sequence | 1 | 2 |
| Received second scan in sequence | 0 | 1 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
| Milestone | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
| Milestone | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI |
|---|---|---|
| Started | 1 | 2 |
| Received first scan in sequence | 0 | 1 |
| Received second scan in sequence | 0 | 1 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
Assessment of whether 68-Ga-RM2 and 68-Ga-PSMA-11 PET/MRI can detect additional cancers over mpMRI. Detection of PC lesions will be assessed by 68Ga PSMA11 and 68Ga RM2 PET scans.
| Participants | 68Ga-RM2 PET MRI | 68Ga-PSMA-11 PET MRI |
|---|---|---|
| Number of Participants With Successful Assessment of PET Based PC Lesions | 2 | 2 |
Assessment of whether 68Ga-RM2 and 68Ga-PSMA-11 PET/MRI can assess changes in response to treatment. Therapeutic response to HDR will be assessed by 68Ga PSMA 11 and 68Ga RM2 PET scans. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | 68Ga-RM2 PET MRI | 68Ga-PSMA-11 PET MRI |
|---|---|---|
| Number of Participants for Which an Assessment of PET Based Therapeutic Response to HDR is Successfully Obtained | 1 | 1 |
Progression-free survival (PFS) will be assessed as survival without progression at 24 months. The outcome is reported as the number (without dispersion) of the participants alive without progression.
No measurements were reported for this outcome.
Collected over up to 13 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Ga-RM2 PET MRI | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| 68Ga-PSMA-11 PET MRI | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 68Ga-RM2 PET MRI Then 68Ga PSMA 11 PET/MRI | 68Ga-PSMA-11 PET MRI Then 68Ga-RM2 PET MRI | Total |
|---|---|---|---|
| United States | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Nov 2022, 33 months.
Results were first posted in Feb 2024, 1 year 2 months after primary completion.
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This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rm-2 ga-68 · Gallium 68 PSMA-11
Andrei Iagaru