68Ga-PSMA-11 PET for Prostate Cancer

Overseen By UCSF Genitourinary Medical Oncology Recruitment

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Disqualifiers: Inability to consent, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called 68Ga-PSMA-11 PET scans to better locate prostate cancer that has spread despite treatments to lower male hormones. The aim is to determine if these scans provide clearer images of cancer's location in the body. This method may suit those with prostate cancer that continues to grow after surgery or hormone-blocking treatments and has spread to other parts of the body. Participants must have at least one tumor visible on these specific scans. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. It seems you can continue your current systemic therapy while participating.

What prior data suggests that 68Ga-PSMA-11 PET is safe for diagnosing prostate cancer?

Research has shown that 68Ga-PSMA-11, used in PET scans, is generally safe. Studies have not reported any serious unexpected reactions. No participants left the study due to the treatment, indicating that the imaging agent is well-tolerated. It helps doctors obtain clearer images of prostate cancer in the body. Overall, 68Ga-PSMA-11 PET appears to be a promising and safe tool for diagnosing prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 68Ga-PSMA-11 PET because it offers a new way to detect prostate cancer more precisely. Unlike traditional imaging methods, 68Ga-PSMA-11 uses a radioactive tracer that binds specifically to the PSMA protein, which is often overexpressed in prostate cancer cells. This targeted approach can potentially identify cancer spread earlier and more accurately than standard imaging techniques like CT or MRI. With this level of precision, doctors can tailor treatments more effectively, potentially improving outcomes for patients.

What evidence suggests that 68Ga-PSMA-11 PET is effective for diagnosing metastatic castration-resistant prostate cancer?

Research has shown that 68Ga-PSMA-11 PET scans, which participants in this trial will undergo, effectively detect prostate cancer that has spread, particularly when other treatments like surgery or hormone therapy are no longer effective. Studies have found this scan to be highly sensitive, accurately locating cancer in the body. In one study, this imaging method correctly identified cancer in 84% to 92% of cases. This accuracy aids doctors in making better treatment decisions by pinpointing the cancer's location. Overall, 68Ga-PSMA-11 PET provides clearer tumor images, improving prostate cancer management. ^{2 5 6 7 8}

Who Is on the Research Team?

Ivan A. de Kouchovsky, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men aged 18+ with prostate cancer that has spread and is resistant to castration treatment. They must be starting or already receiving systemic therapy, have a detectable metastatic lesion on a PSMA PET scan, and meet health criteria like sufficient platelet counts. Men unable to give informed consent or follow the study procedures are excluded.

Inclusion Criteria

Sub-cohort A1: Patients must have baseline evaluations performed within 12 weeks prior to the start of systemic therapy.

I had a biopsy after my baseline Ga-PSMA PET scan.

My biopsy target has not received radiation.

Exclusion Criteria

I am unable to give informed consent due to my age or health condition.

Patients with any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.

Patients with any contra-indication to magnetic resonance imaging (MRI) (e.g. pacemaker placement, severe claustrophobia) Note: The exclusion criteria above (3) is only applicable for patients scheduled for a Positron Emission Tomography (PET) MRI (PET/MRI).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants receive gallium Ga 68-PSMA-11 intravenously and undergo PET imaging

1 day

1 visit (in-person)

Follow-up Imaging

Participants undergo PET imaging 16 weeks after initiating therapy to assess changes in SUVmax

16 weeks

1 visit (in-person)

Disease Progression Imaging

Participants undergo PET imaging at the time of disease progression

Variable

1 visit (in-person)

Long-term Follow-up

Participants are followed up every 3 months for up to 24 months to monitor overall survival and progression-free survival

24 months

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-PSMA-11

Trial Overview The trial studies the effectiveness of a new imaging agent called 68Ga-PSMA-11 used in PET scans for better tumor detection in metastatic castration-resistant prostate cancer. It aims to improve disease location identification which could enhance treatment planning.

How Is the Trial Designed?

Group I: Experimental (68Ga-PSMA-11 PET) Experimental Treatment 2 Interventions

Patients receive gallium 68Ga-PSMA-11 IV and undergo PET at baseline, 16 weeks after initiating therapy, and at time of disease progression.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Conquer Cancer Foundation

Collaborator

Trials

22

Recruited

4,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36900169/

Detection Efficacy of 68 Ga-PSMA-11 PET/CT in ... In biochemical recurrence of prostate cancer (BCR), prompt tumor localization guides early treatment, potentially improving patient outcomes.

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233460

Quantitative 68 Ga-PSMA-11 PET and Clinical Outcomes ... Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30350010/

68Ga-PSMA-11 PET/CT in recurrent prostate cancer Our data confirmed the efficacy of 68 Ga-PSMA-11 PET/CT for detecting local vs systemic disease in PCa patients presenting PSA failure after radical therapy ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/65/3/379

Diagnostic Performance of 68Ga-PSMA-11 PET/CT Versus ... For detecting intraprostatic radiorecurrence, 68 Ga-PSMA-11 PET/CT has high sensitivity that is not significantly different from mpMRI.

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2729065

Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing ... Findings In this prospective single-arm trial of 635 men, 68Ga-PSMA-11 PET demonstrated 84% to 92% positive predictive value at 75% overall ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39162634/

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ... Whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy, with a hazard ratio (HR) range of 0.86-1.43 for all outcomes (all P < .001). A 1- ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251888

Impact of 68Ga-PSMA-11 PET/CT on Clinical Management of ... 68 Ga-PSMA-11 PET/CT is a promising diagnostic tool in the work-up of PCa patients in the real world, demonstrating an overall positivity rate of 94%.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612191/

A Phase II, Open-Label Study to Assess Safety and ... Conclusion: 68Ga-THP PSMA was safe to use, with no serious AEs and no AEs resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of ...