PSMA-PET/CT Scans for Prostate Cancer

Recruiting in Boston (>99 mi)

+1 other 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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 18F-rhPSMA-7.3 for prostate cancer?

Research shows that 18F-rhPSMA-7.3 PET/CT scans are effective in detecting prostate cancer, including primary tumors and metastatic lesions, with good accuracy. It has been shown to identify cancerous lesions that other standard imaging methods might miss, making it a valuable tool for diagnosing and managing prostate cancer. ^{1 2 3 4 5}

Is 18F-rhPSMA-7.3 safe for use in humans?

The studies on 18F-rhPSMA-7.3 and similar agents like 18F-PSMA 1007 primarily focus on their effectiveness in detecting prostate cancer, but they do not report any specific safety concerns in humans. These agents are used in imaging and have been tested in both healthy volunteers and patients, suggesting they are generally considered safe for use in clinical settings. ^{3 4 5 6 7}

How does PSMA-PET/CT differ from other treatments for prostate cancer?

PSMA-PET/CT is unique because it uses a special imaging technique with a radiopharmaceutical called 18F-rhPSMA-7, which is more effective at detecting prostate cancer spread compared to traditional imaging methods like CT or MRI. This approach provides better accuracy in identifying cancerous lymph nodes and bone lesions, making it a valuable tool for staging and treatment planning. ^{3 5 6 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches. The main questions it aims to answer are: What is the proportion of men with residual PSMA-avid disease on PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer? Do the findings on PSMA-PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status, like PSA? Participants will: Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PET/CT scan before starting treatment Undergo a PSMA-PET/CT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan

Research Team

Heather Jacene

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-rhPSMA-7 PET for the Detection of Biochemical Recurrence of Prostate Cancer After Radical Prostatectomy. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-PET/CT in Patients With Biochemical Prostate Cancer Recurrence and Negative 18F-Choline-PET/CT. [2022]

3. United States 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. [2020]

4. United States 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. [2022]

5. United States 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. [2022]

6. England 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. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Real-world Israeli single institution experience with PET-PSMA for staging of patients with clinically staged localized prostate carcinoma. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. [2022]