Using a new imaging test for prostate cancer before treatment
A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer
This study is testing a new imaging scan to see how well it can show the spread of advanced prostate cancer before starting treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06099093 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of 18F-DCFPyL PSMA PET imaging in assessing the extent of metastatic castration-resistant prostate cancer (mCRPC) prior to treatment with 177Lu-vipivotide tetraxetan. It is a one-arm, single-stage prospective study involving a single PET scan and the collection of medical record data. The study will include approximately 30 participants who have confirmed prostate cancer and are scheduled for the approved therapy. The goal is to determine how well this imaging test compares to another established diagnostic scan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed prostate cancer who are scheduled to receive 177Lu-vipivotide tetraxetan therapy.
Not a fit: Patients without confirmed prostate cancer or those not scheduled for 177Lu-vipivotide tetraxetan therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy for prostate cancer, leading to better treatment planning.
How similar studies have performed: Other studies have shown success with similar imaging approaches, but this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have histologically or cytologically confirmed prostate cancer. * Age ≥18 years. * Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET. -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy). * Ability and willingness to comply with the study procedures. * 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. * The effects of 18F-DCFPyL 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 the 18F-DCFPyL PSMA-PET scan. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Contraindications to PET/CT, including severe claustrophobia. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL * 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)
- Brigham and Womens Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Heather Jacene, MD — Dana-Farber Cancer Institute
- Study coordinator: Heather Jacene, MD
- Email: hjacene@partners.org
- 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.