PSMA-PET/CT Scans for Prostate Cancer

Not currently recruiting at 1 trial location

Overseen By Heather A Jacene, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must be taking: ADT, AR inhibitors

Must not be taking: Other systemic therapies

Disqualifiers: Uncontrolled illness, Radiation, Allergic reactions, 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: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special PSMA-PET/CT scans can effectively track prostate cancer's response to treatment, particularly when the cancer has spread and remains hormone-sensitive. The trial seeks to discover how many men show signs of the disease after six months of treatment and whether these scans align with other assessment methods, such as PSA tests. Men diagnosed with metastatic hormone-sensitive prostate cancer who are beginning specific treatments might be suitable candidates. Participants will receive standard treatment, including 18F-rhPSMA-7.3 (a radiotracer used in imaging), and undergo two PSMA-PET/CT scans—one before starting treatment and another after six months—with follow-up reviews for a year. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does not allow systemic therapies other than ADT, AR pathway inhibitors, and docetaxel during the study. It's best to discuss your current medications with the study team to see if they are allowed.

What is the safety track record for PSMA-PET/CT scans?

Research has shown that 18F-rhPSMA-7.3 is generally safe and well-tolerated. In studies with healthy individuals, it produced positive safety results, with most participants not experiencing major side effects. Another study found it was also well-tolerated by patients with newly diagnosed prostate cancer, meaning it didn't cause significant problems or discomfort for most.

The treatment offers a favorable benefit-to-risk balance, indicating that the potential benefits outweigh the risks for many patients. Overall, current data suggests the treatment is safe. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about 18F-rhPSMA-7.3 in prostate cancer treatment because this compound enhances imaging precision by targeting the Prostate-Specific Membrane Antigen (PSMA), which is abundant on prostate cancer cells. Unlike traditional imaging methods, such as bone scans or CT scans, which might miss smaller or less active tumors, 18F-rhPSMA-7.3 PET/CT scans can provide a more detailed and accurate picture of cancer spread. This increased accuracy helps in tailoring more effective treatment plans for patients, potentially leading to better outcomes.

What evidence suggests that PSMA-PET/CT scans are effective for monitoring prostate cancer?

Research has shown that 18F-rhPSMA-7.3 PET/CT scans, which participants in this trial will undergo, effectively detect prostate cancer, particularly when there is concern about recurrence after initial treatment. Studies have demonstrated that this imaging method successfully identifies cancer in patients showing signs of recurrence post-surgery. It also evaluates treatment effectiveness in patients with metastatic cancer, aiding doctors in making informed decisions. These scans can reveal changes in the cancer and help monitor treatment progress. Overall, PSMA-PET/CT imaging is a valuable tool for managing and understanding prostate cancer progression. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Jacene

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for men with metastatic hormone-sensitive prostate cancer. Participants will receive standard care and undergo PSMA-PET/CT scans before and after 6 months of treatment to track disease response.

Inclusion Criteria

Serum testosterone >150 ng/dL

Ability and willingness to comply with the study procedures

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3

I am not on any cancer treatments except for hormone therapy or specific prostate cancer medications.

I have not had radiation to my prostate or any cancer spread sites before a 6-month PET scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo a baseline 18F-rhPSMA-7.3 PSMA-PET/CT scan before starting treatment

1 day

1 visit (in-person)

Treatment

Participants receive standard of care treatment for metastatic hormone sensitive prostate cancer

6 months

Interim Imaging

Participants undergo a PSMA-PET/CT scan after 6 months of treatment to evaluate changes in disease extent

1 day

1 visit (in-person)

Follow-up

Participants are monitored via chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-rhPSMA-7.3

Trial Overview The study tests if serial PSMA-PET/CT scans can effectively monitor the response to therapy in patients with metastatic hormone-sensitive prostate cancer, aiming to improve future treatments.

How Is the Trial Designed?

Group I: PSMA-PET/CT arm Experimental Treatment 2 Interventions

Patients will undergo 18F-rhPSMA-7.3 PSMA PET/CT scan before and after 6 months of treatment for metastatic hormone sensitive prostate cancer. Patients will undergo chart review every 3 months for 1 year after the second 18F-rhPSMA-7.3 PSMA PET/CT scan.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

In a study of eight patients with newly diagnosed intermediate-risk prostate cancer, false-positive results from PET-PSMA scans were identified, highlighting the need for careful interpretation of this imaging technique despite its high sensitivity.

All patients ultimately received definitive treatment and remained disease-free, indicating that while PET-PSMA is a powerful tool, clinical judgment is crucial to avoid unnecessary interventions based on false-positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world Israeli single institution experience with PET-PSMA for staging of patients with clinically staged localized prostate carcinoma. Zarbiv, Y., Peerless, Y., Wygoda, M., et al.[2022]

In a study of 242 patients with biochemical recurrence after prostate surgery, 18F-rhPSMA-7.3 PET/CT demonstrated a high detection rate of 72.7%, with efficacy increasing with higher PSA levels, reaching 95.7% for PSA ≥2 ng/mL.

The use of 18F-rhPSMA-7.3 PET/CT led to a change in therapeutic management for 63.2% of patients, indicating its significant impact on clinical decision-making prior to salvage therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection efficacy of 18F-rhPSMA-7.3 PET/CT and impact on patient management in patients with biochemical recurrence of prostate cancer after radical prostatectomy and prior to potential salvage treatment. Rauscher, I., Karimzadeh, A., Schiller, K., et al.[2022]

In a study comparing 160 patients using 18F-rhPSMA-7 and 68Ga-PSMA-11 for prostate cancer imaging, both tracers showed high tumor positivity rates, but 18F-rhPSMA-7 had a significantly higher tumor-to-bladder ratio, indicating better imaging clarity.

18F-rhPSMA-7 also revealed a greater number of benign lesions compared to 68Ga-PSMA-11, suggesting that while both tracers are effective, 18F-rhPSMA-7 may lead to more accurate differentiation between benign and malignant lesions when properly interpreted by trained physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matched-Pair Comparison of 68Ga-PSMA-11 and 18F-rhPSMA-7 PET/CT in Patients with Primary and Biochemical Recurrence of Prostate Cancer: Frequency of Non-Tumor-Related Uptake and Tumor Positivity. Kroenke, M., Mirzoyan, L., Horn, T., et al.[2022]

In a study of 261 patients with biochemical recurrence of prostate cancer, 18F-rhPSMA-7 PET/CT demonstrated high detection rates of 81% for recurrent lesions, even at low PSA levels, indicating its efficacy as a diagnostic tool.

The detection rates improved with higher PSA levels, reaching 95% for patients with PSA ≥2 ng/mL, suggesting that 18F-rhPSMA-7 is particularly effective for early detection of recurrence after radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. Eiber, M., Kroenke, M., Wurzer, A., et al.[2020]

In a study of 58 high-risk prostate cancer patients, 18F-rhPSMA-7 PET imaging demonstrated significantly better performance than traditional morphologic imaging (CT or MRI) for detecting lymph node metastases, with a sensitivity of 72.2% compared to 50.0%.

The accuracy of 18F-rhPSMA-7 PET was also higher, achieving 86.2% accuracy in patient-based analyses versus 65.5% for morphologic imaging, indicating its potential as a more effective tool for N-staging in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologically Confirmed Diagnostic Efficacy of 18F-rhPSMA-7 PET for N-Staging of Patients with Primary High-Risk Prostate Cancer. Kroenke, M., Wurzer, A., Schwamborn, K., et al.[2020]

The novel radiopharmaceutical 18F-rhPSMA-7.3 demonstrated high efficacy in detecting prostate cancer lesions, identifying all primary tumors in high-risk localized cases and all known metastatic lesions in patients with hormone-sensitive and castration-resistant prostate cancer.

In a small study of 10 patients, 18F-rhPSMA-7.3 showed a strong correlation between the maximum standardized uptake value (SUVmax) of prostate lesions and higher Gleason scores, indicating its potential for accurately identifying more aggressive cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of 18F-rhPSMA-7.3 in Positron Emission Tomography Imaging of Prostate Cancer: A Phase 1 Proof-of-Concept Study. Malaspina, S., Taimen, P., Kallajoki, M., et al.[2022]

F-18-PSMA-1007-PET is effective for staging prostate cancer, particularly in identifying seminal vesicle invasion, outperforming mpMRI with a correct staging rate of 90% compared to 76%.

The study suggests that combining F-18-PSMA-1007-PET with mpMRI could enhance the overall accuracy of prostate cancer staging, as mpMRI was better at detecting extracapsular extension (90% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. Privé, BM., Israël, B., Schilham, MGM., et al.[2022]

In a study of 125 prostate cancer patients with biochemical recurrence, the sequential imaging approach using Ga-PSMA-PET/CT after negative F-choline-PET/CT significantly improved detection rates of recurrent disease, achieving an overall detection rate of 85.6%.

Ga-PSMA-PET/CT was particularly effective in identifying recurrence in 43.8% of patients who had negative F-choline scans, with detection rates increasing with higher PSA levels, indicating its potential as a valuable tool in managing prostate cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-PET/CT in Patients With Biochemical Prostate Cancer Recurrence and Negative 18F-Choline-PET/CT. Bluemel, C., Krebs, M., Polat, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8612184/

Detection Efficacy of 18F‐rhPSMA‐7.3 PET/CT and Impact ... Conclusion: 18F-rhPSMA-7.3 PET offered high detection efficacy in patients with biochemical recurrence after radical prostatectomy and before potential salvage ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06442

An Imaging Scan (18FrhPSMA-7.3 PSMA-PET-CT) for ... 18F-rhPSMA-7.3 PET-CT is used to find prostate cancer when it is suspected the cancer has come back after initial therapy for localized disease (recurrent) or ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825232

Outcomes of PSMA-PET Imaging of Recurrent Prostate ... Upfront PSMA-PET imaging for the evaluation of BCR is expected to be associated with reduced cancer mortality and gains in life-years and QALYs.

4. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/252071

Preliminary evaluation of PSMA PET/CT for treatment ... Conclusions: PSMA PET/CT is valuable for treatment response assessment in metastatic prostate cancer patients undergoing systemic therapies and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06479187

PSMAtrack-tracking Changes in PSMA-PET During Initial ... Patients will undergo 18F-rhPSMA-7.3 PSMA PET/CT scan before and after 6 months of treatment for metastatic hormone sensitive prostate cancer. Patients will ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844263/

Safety, Biodistribution, and Radiation Dosimetry of 18F- ... The present data acquired in healthy subjects indicate that 18F-rhPSMA-7.3 is a well-tolerated PET radiopharmaceutical with a favorable radiation dosimetry ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0302283823029494

Diagnostic Performance and Safety of Positron Emission ... Overall, 18F-rhPSMA-7.3-PET/CT was well tolerated, and identified N1 and M1 disease prior to surgery in newly diagnosed PCa patients. Patient summary. In order ...

8. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003493

Diagnostic Performance and Safety of 18 F-rhPSMA-7.3 ... The overall 18F-rhPSMA-7.3 detection rate among all 389 patients with an evaluable scan was 83% (majority read). Among the 366 patients (median ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828651

PSMA-PET/CT Findings in Patients With High-Risk ... PSMA-PET was highly associated with response to SRT and was associated with 3-year freedom from progression more accurately than clinical ...

10. urotoday.com urotoday.com/conference-highlights/suo-2022/suo-2022-prostate-cancer/141069-suo-2022-diagnostic-performance-and-safety-of-18f-rhpsma-7-3-pet-in-patients-with-newly-diagnosed-prostate-cancer-results-from-a-phase-3-prospective-multicenter-study-lighthouse.html

Diagnostic Performance and Safety of 18F-rhPSMA-7.3 ... F-rhPSMA-7.3 is well tolerated by patients and exhibits a favorable benefit to risk ratio in men with newly diagnosed prostate cancer scheduled for radical ...