Ga-68 PSMA PET/CT for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Michael Graham PhD, MD

Must not be taking: Furosemide, Sulfa drugs

Disqualifiers: Stevens-Johnson syndrome, Paget's disease, 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new drug called Ga-68 PSMA-HBED-CC, a radiotracer, to determine if it can enhance the visibility of prostate cancer on PET scans. By improving cancer detection, treatments can be more precisely targeted to the disease's location in the body. Participants receive a small dose of radiation through an injection, followed by a PET scan to capture images for their medical records. Men with prostate cancer and rising PSA levels after surgery or radiation may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drugs, and you should not have uncontrolled illnesses that might affect your participation.

Is there any evidence suggesting that Ga-68 PSMA PET/CT is likely to be safe for humans?

Research has shown that Ga-68 PSMA-HBED-CC, a new drug used in PET scans for prostate cancer, is generally safe. One study reported no serious side effects, and no participants withdrew due to adverse effects, indicating the treatment is well-tolerated. The Ga-68 PSMA drug involves a small amount of radiation, less than the annual exposure limit for medical workers. Overall, the research indicates that this treatment is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for prostate cancer?

Researchers are excited about Ga-68 PSMA-HBED-CC PET/CT scans for prostate cancer because this imaging technique offers a more precise method for detecting cancerous cells. Unlike traditional imaging methods, which may struggle to identify small or early-stage tumors, Ga-68 PSMA PET/CT uses a special molecule that binds specifically to prostate cancer cells, making them much easier to spot. This targeted approach could lead to earlier and more accurate diagnoses, potentially improving treatment decisions and outcomes for patients.

What evidence suggests that Ga-68 PSMA PET/CT is effective for identifying prostate cancer?

Research shows that Ga-68 PSMA PET/CT scans, which participants in this trial will undergo, effectively detect prostate cancer. Studies indicate that these scans correctly identify prostate cancer in 81.2% of cases confirmed by surgery, with even higher accuracy in some groups. Ga-68 PSMA scans have a success rate of about 65% to 75% in detecting cancer, making this imaging method a strong tool for identifying and understanding prostate cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael M Graham, Ph.D., MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer that has returned after surgery or radiation therapy. They must have a specific level of PSA, a protein linked to prostate cancer, in their blood and be generally healthy without other recent cancers (except certain skin or superficial bladder cancers). Participants can't join if they're taking experimental drugs, allergic to sulfa medications, have heart problems, uncontrolled illnesses, or conditions affecting study compliance.

Inclusion Criteria

You are not taking any experimental drugs that have not been approved by regulatory agencies for testing their effectiveness.

I can understand and agree to participate in the study.

My PSA levels are increasing after having surgery or radiation for prostate cancer.

Exclusion Criteria

You are allergic to medications that contain sulfa.

I have no other cancer besides the one currently being studied.

You have had Stevens-Johnson syndrome in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an injection of Ga-68 PSMA and undergo a PET scan to identify prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness of the imaging results, with clinical follow-up and additional imaging as needed

12 months

Optional Second Imaging

Participants may be invited for a second 68Ga PSMA scan if initial results show positive lymph nodes or metastases

What Are the Treatments Tested in This Trial?

Interventions

• Ga-68 PSMA-HBED-CC PET

Trial Overview The trial tests whether injecting Ga-68 PSMA before PET/CT imaging helps better detect where the prostate cancer is located. This could lead to more targeted treatments. The drug contains a small amount of radioactive material but within safe exposure limits for patients.

How Is the Trial Designed?

Group I: 68Ga PSMA PET scan Experimental Treatment 1 Intervention

Ga-68 PSMA-HBED-CC PET/CT scan

Who Is Running the Clinical Trial?

Michael Graham PhD, MD

Lead Sponsor

Trials

3

Recruited

290+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8322807/

Performance of Ga-68 PSMA PET/CT for diagnosis and ... The sensitivity of PSMA PET/CT for the detection of RP-confirmed prostate cancer was 81.2%. Much higher sensitivity was found within certain subpopulations. The ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/63/2/240

Diagnostic Performance and Clinical Impact of 68 Ga-PSMA ... The PSMA PET/CT positivity rate was 65.1%, similar to the positivity rates reported in other studies, ranging overall from 63% to 75% (10,14,16, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03389451

68Ga PSMA PET for Patients With Biochemical Recurrence ... This study investigates if a new prostate-specific membrane antigen (PSMA) drug makes prostate cancer easier to identify in positron-emission tomography (PET) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1558767324000478

An Update on the Role of mpMRI and 68Ga-PSMA PET ... The findings indicated that 68Ga-PSMA-PET/CT effectively diagnosed prostate cancer in patients with suspected or confirmed disease, and both methods exhibited ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5439210/

Clinical Utility of Gallium-68 PSMA PET/CT Scan for ... Ga68-PSMA scan resulted in the detection of extra-prostatic disease in 53.2% of cases when done at baseline before commencing any treatment. The sensitivity of ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/62/12/1727

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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03396874

Study Details | NCT03396874 | Gallium-68 PSMA-11 PET ... This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283816000117

Simultaneous 68Ga-PSMA HBED-CC PET/MRI Improves ... Simultaneous 68 Ga-PSMA HBED-CC PET/MRI improves diagnostic accuracy for PCa localization both compared with mpMRI and with PET imaging alone.