Tracking changes in prostate cancer using PSMA-PET scans during treatment
PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer
This study is testing if regular PSMA-PET scans can help track how well treatment is working for men with advanced prostate cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06479187 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of serial PSMA-PET/CT scans in monitoring the response to therapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Participants will receive standard treatment and undergo PSMA-PET/CT scans before and after six months of therapy to assess changes in disease extent and correlate these findings with prostate-specific antigen (PSA) levels. The study seeks to determine the proportion of patients with residual PSMA-avid disease after treatment and explore the potential for optimizing future treatment strategies based on imaging results.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with confirmed metastatic hormone-sensitive prostate cancer who are about to start systemic therapy.
Not a fit: Patients who have received systemic therapy in the past six months or those with non-metastatic prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and personalized treatment strategies for patients with metastatic hormone-sensitive prostate cancer.
How similar studies have performed: Other studies have shown promise in using PSMA-PET imaging for prostate cancer, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed prostate cancer, or unequivocal clinical evidence of mHSPC (eg. elevated PSA with lesions consistent with metastatic prostate cancer). 2. Age ≥18 years. 3. Participants must have mHSPC (either de novo or relapse after prior local therapy), as defined by extrapelvic nodal and/or visceral and/or bone lesions consistent with metastatic disease and seen on CT, bone scan and/or MRI. If participants have relapsed after prior local therapy, they must not have had systemic therapy in the past 6 months prior to study registration. 4. Serum testosterone \>150 ng/dL. 5. Planned initiation of systemic therapy with ADT (androgen deprivation therapy) and an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) ± docetaxel. Initiation of systemic therapy up to 14 days prior to the baseline 18F-rhPSMA-7.3 PSMA-PET/CT is permitted. 6. Ability and willingness to comply with the study procedures. 7. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial. 8. The effects of 18F-rhPSMA-7.3 on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after each 18F-rhPSMA-7.3 PSMA-PET scan. 9. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Systemic therapies other than ADT (GnRH/LHRH agonists or antagonists), AR pathways inhibitors (abiraterone, enzalutamide, apalutamide, darolutamide) and docetaxel are not permitted to be administered during the study period. 2. Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Contraindications to PET/CT, including severe claustrophobia. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3. 6. Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Heather Jacene, MD — Brigham and Women's Hospital
- Study coordinator: Heather A Jacene, MD
- Email: hjacene@bwh.harvard.edu
- Phone: 617-632-3767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.