A Phase 2 interventional study of 68Ga RM2 and 68Ga-PSMA-11 in Prostate Cancer, sponsored by Andrei Iagaru. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Andrei Iagaru · Phase 2, Interventional, and Diagnostic
Among 49 studies testing gallium 68 PSMA-11 in Prostatic Neoplasms — 8 open to participants now, 11 under way, 3 of them phase 3. gallium 68 PSMA-11 · Prostatic Neoplasms.
Among the 49 studies testing gallium 68 PSMA-11 in Prostatic Neoplasms, this one is the 36th largest by enrollment, is one of 5 that started in 2019, is one of 19 in phase 2, and was the 19th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 14 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →8 of the 49 studies testing gallium 68 PSMA-11 in Prostatic Neoplasms are open now, in 4 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →49 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 5 started in 2019.
Median enrollment 50 across the 49 interventional studies. Of the 31 that completed or were terminated, 18 (58%) have results posted.
4 of 49 have an industry lead sponsor. The 10 most frequent:
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.
Andrei Iagaru has 6 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies testing gallium 68 PSMA-11 in Prostatic Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07052214Phase 3Telix Pharmaceuticals (Innovations) Pty LimitedPSMA PET Combined With MRI for the Detection of PCa | 2027-01 |
| NCT05849298Novartis PharmaceuticalsA Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC | 2026-12-23 |
| NCT07747493University Health Network, Toronto68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy | 2027-07-31 |
Among the 49 studies testing gallium 68 PSMA-11 in Prostatic Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Exploratory Objective:
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11
Drug: 68Ga RM2 · Drug: 68Ga-PSMA-11 · Device: Investigational PET scanner coils and software
Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2
Drug: 68Ga RM2 · Drug: 68Ga-PSMA-11 · Device: Investigational PET scanner coils and software
PET radiopharmaceutical
Also known as: 68Ga DOTA Bombesin, BAY86 7548
PET radiopharmaceutical
Also known as: DFKZ 11, HBED CC PSMA, Heidelberg compound
GE Healthcare non-approved PET scanner coils and software
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
Time frame: Up to approximately 2 hours to complete each scan
| Milestone | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
| Milestone | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
| Participants | 68Ga PSMA11 | 68Ga RM2 |
|---|---|---|
| Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | 13 | 13 |
Collected over 2 weeks, plus safety follow up at to 72 hours after the final scan. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Ga PSMA11 | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| 68Ga RM2 | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| Mean | 63.4 ± 4.4 | 55.7 ± 7.3 | 59.6 ± 7.2 |
| Sex: Female, Male(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 7 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 3 | 5 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | 68Ga PSMA11 First Followed by 68Ga RM2 | 68Ga RM2 First Followed by 68Ga PSMA11 | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
Plan to share: No
This study is completed, 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