PSMA PET Scan for Prostate Cancer

Overseen By William Aronson, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: VA Greater Los Angeles Healthcare System

Disqualifiers: Under 18, Serious illness, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining a new imaging technique, PSMA PET, with mpMRI (multiparametric Magnetic Resonance Imaging) can detect significant prostate cancer more effectively than mpMRI alone. Participants will be divided into two groups: one will receive both PSMA PET and mpMRI scans, while the other will undergo only the mpMRI scan. The study seeks men who have already had an mpMRI indicating a high suspicion of prostate cancer and are planning a prostate biopsy. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in prostate cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that PSMA PET and mpMRI have promising safety results. Research indicates these imaging methods have acceptable toxicity levels, meaning they don't significantly harm patients. For instance, reports of moderate or severe side effects related to the urinary, reproductive, stomach, and intestines remained within acceptable limits. Additionally, patients reported a good quality of life while undergoing these imaging techniques. This suggests that the treatments are generally well-tolerated and safe for detecting prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the PSMA PET scan for prostate cancer because it's a game-changer in imaging techniques. Unlike standard options like traditional MRI or CT scans, PSMA PET scans use a special tracer that binds to the prostate-specific membrane antigen, PSMA, which is highly expressed on prostate cancer cells. This allows for more precise detection and staging of prostate cancer, potentially leading to better treatment decisions. The combination with mpMRI in the trial aims to enhance accuracy even further, offering a more comprehensive view of the cancer's extent. This could ultimately improve outcomes by tailoring treatments more effectively to the patient's specific condition.

What evidence suggests that PSMA PET and mpMRI could be effective for detecting prostate cancer?

Research has shown that using PSMA PET scans with mpMRI scans helps doctors identify significant cases of prostate cancer more effectively. In this trial, one group of participants will receive both PSMA PET and mpMRI-guided prostate biopsy, which studies have shown increases cancer detection rates from 83% to 97% compared to mpMRI alone. Another study highlighted that PSMA PET excels at detecting cancer that has spread to other parts of the body, such as lymph nodes, revealing areas that mpMRI might miss. Overall, using both PSMA PET and mpMRI enhances doctors' ability to accurately find and diagnose prostate cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

William Aronson, MD

Principal Investigator

VA Greater Los Angeles Healthcare System

Are You a Good Fit for This Trial?

This trial is for men with suspected clinically significant prostate cancer, indicated by a PI-RADS score of 4-5 from an mpMRI. Participants must have had this imaging within the last 9 months and be willing to undergo a biopsy. They should be able to consent and agree to random assignment in the study but cannot join if under 18 or have health issues that could affect their participation.

Inclusion Criteria

I had a prostate MRI within the last 9 months.

I can sign and understand the consent form.

I have a high-risk prostate lesion and will have a biopsy.

Exclusion Criteria

Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance

My kidney function is good enough for a prostate MRI.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Imaging

Participants are randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy

1 week

Biopsy Procedure

Participants undergo fusion guided prostate biopsy based on mpMRI and PSMA scans or mpMRI alone

1 week

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mpMRI
• PSMA PET

Trial Overview The study is testing whether combining PSMA PET scans with mpMRI can better detect important prostate cancers compared to using mpMRI alone. It's a phase 2 trial where patients are randomly chosen to either get just an mpMRI or an additional DCFPyL PET/CT scan.

How Is the Trial Designed?

Group I: PSMA PET+mpMRI Experimental Treatment 2 Interventions

PSMA PET+mpMRI guided prostate biopsy

Group II: mpMRI only Active Control 1 Intervention

mpMRI only guided prostate biopsy

mpMRI is already approved in European Union, United States for the following indications:

Approved in European Union as Multiparametric MRI for:

• Prostate cancer diagnosis
• Active surveillance of low-risk prostate cancer
• Risk stratification for targeted biopsy

Approved in United States as Multiparametric MRI for:

• Prostate cancer diagnosis
• Active surveillance of low-risk prostate cancer
• Risk stratification for targeted biopsy

Who Is Running the Clinical Trial?

VA Greater Los Angeles Healthcare System

Lead Sponsor

Trials

53

Recruited

8,700+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

Published Research Related to This Trial

In a pilot study of 62 patients with suspected or defined prostate cancer, PSMA-PET/MRI imaging led to a change in management strategies for 41.9% of patients, indicating its potential clinical utility in guiding treatment decisions.

The most significant impact of PSMA-PET/MRI was observed in patients with biochemical recurrent prostate cancer, particularly those with PSA levels between 0.5 and 1 ng/ml, suggesting that this imaging technique can help refine treatment approaches in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of 18F-PSMA-1007 Positron Emission Tomography/Magnetic Resonance Imaging in Prostate Cancer: A Single-Center Experience. Liu, A., Zhang, M., Huang, H., et al.[2022]

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

The study demonstrated that a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol is feasible and reproducible for imaging prostate cancer in eight high-risk patients, effectively detecting dominant lesions and providing complementary staging information.

The results showed strong correlation between SUVmean values from PET/CT and PET/MRI, indicating that this combined imaging approach can enhance the accuracy of prostate cancer assessment while minimizing artifacts, thus improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. Freitag, MT., Kesch, C., Cardinale, J., et al.[2019]

In a study of ten patients with primary prostate cancer, both multi-parametric MRI (MP-MRI) and PSMA-PET/CT effectively identified tumor locations, showing high agreement in tumor staging based on biopsy results.

PSMA-PET/CT demonstrated a strong correlation with MP-MRI, identifying tumors in 89.4% of sections marked by MP-MRI and 96.8% of sections marked by PSMA-PET, suggesting that PSMA-PET/CT could be a reliable alternative for staging prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of (68)Ga-PSMA-11-PET/CT and multi-parametric MR for imaging of primary prostate cancer. Giesel, FL., Sterzing, F., Schlemmer, HP., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11337997/

Head-to-head comparison of PSMA PET/CT and mpMRI for ... Although mpMRI demonstrated better diagnostic accuracy for detecting local recurrence, PSMA PET/CT was superior in detecting distant and lymph node metastases.

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034977/

Impact of PSMA PET on Prostate Cancer Management PSMA PET and MRI combined increased the sensitivity from 83 to 97% and the negative predictive value from 72 to 91% compared to MRI alone. In a ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233023

PSMA PET Parameters for Predicting Outcomes in Patients ... PSMA PET/CT is a valuable tool with which to identify and locate the primary prostate tumor and early metastatic lesions. When compared with ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/65/4/555

The Value of 68Ga-PSMA PET/MRI for Classifying Patients ... Our previous study found that the combination of mpMRI and 68Ga-PSMA PET/CT improved the diagnostic accuracy of csPCa compared with mpMRI alone, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12337896/

Integration of prostate-specific membrane antigen-PET and ... Multiple phase I/II trials using PSMA-PET and mpMRI have reported acceptable acute and late toxicity profiles. Nevertheless, extensive data on ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025001781

Safety and quality of life of PSMA-PET- and MRI-based ... Acceptable rates of grade 2 + GU/GI toxicities and good quality of life. mpMRI and PSMA-PET focal dose escalated definitive RT is safe and feasible.

8. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00326-7/fulltext

Combining PSMA-PET and PROMISE to re-define disease ... Our findings confirm the combined PSMA-PET and PROMISE metrics to be an accurate prognostic biomarker in early and late stages of prostate ...

9. urotoday.com urotoday.com/conference-highlights/aua-2024/aua-2024-prostate-cancer/151798-aua-2024-updates-in-prevention-diagnostics-and-surgery-psma-pet-updates.html

AUA 2024: Updates in Prevention, Diagnostics and Surgery Of these 291 men, 162 (56%) had clinically significant prostate cancer. MRI, PSMA, and PSMA+MRI was positive in 67%, 73%, and 81% of patients, ...