Using a new imaging test for prostate cancer before treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• JANX014 for metastatic castration-resistant prostate cancer

  This trial will test whether JANX014 is safe, how your body handles it, and whether it shows signs of benefit in adults with metastatic castration-resistant prostate cancer who have already had anti-androgen therapy and typically a taxane.

  Recruiting at 6 sites Phase 1 Janux Therapeutics · La Jolla, California and 5 other locations · NCT07545811

• Actinium (225Ac) PSMA therapy for castration‑resistant prostate cancer after Lutetium

  This trial will test whether an injectable Actinium-225 PSMA treatment can control advanced prostate cancer in men whose disease progressed after Lutetium‑PSMA therapy.

  Recruiting Phase 1/2 University College, London · London · NCT07414940

• A-CAR032 CAR-T therapy for metastatic castration-resistant prostate cancer

  This early-phase treatment will try A-CAR032, a CAR-T cell therapy, in adults with metastatic castration‑resistant prostate cancer who progressed after ARPI and are not eligible for standard treatment.

  Recruiting at 2 sites Phase 1 Shanghai AbelZeta Ltd. · Beijing, Beijing Municipality and 3 other locations · NCT07344311

• ASP5541 with prednisone and ADT for Chinese men with prostate cancer

  This study tests whether giving ASP5541 together with prednisone and ongoing androgen-deprivation therapy is safe and how the medicine behaves in Chinese men with metastatic prostate cancer.

  Recruiting Phase 1 Astellas Pharma Inc · Beijing, Beijing Municipality · NCT07339267

• Phase 2 test of ASP5541 for men with advanced prostate cancer

  This study will test whether an injectable form of abiraterone (ASP5541) is safe and works as well or better than the standard oral abiraterone for men with metastatic prostate cancer who are on hormone therapy, with or without prednisone.

  Recruiting at 54 sites Phase 2 Astellas Pharma Inc · Huntsville, Alabama and 53 other locations · NCT07005154

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.