Phase 4 Prostate Cancer Trial, Recruiting NCT06099093 Sponsor: Brigham and Women's Hospital Condition: Prostate Cancer
Back to Prostate Cancer

Phase 4 Prostate Cancer Trial, Recruiting

NCT06099093
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with prostate cancer confirmed by a laboratory test on tissue or cell samples.
  • People who are 18 years of age or older.
  • People who are already planned to receive a standard treatment called 177Lu-Vipivotide Tetraxetan following a specific type of scan (18F-DCFPyL PSMA-PET).
  • People who have had a specific type of scan (68Ga-PSMA-11 PSMA-PET) within the last 120 days showing at least one area of concern detected by that scan, as required to be eligible for the 177Lu-Vipivotide Tetraxetan treatment.
  • People who are able and willing to follow all study procedures.
  • People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to affect the safety or results of this study (confirm with trial site).
  • Women who could become pregnant, and men, must agree to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before joining the study and for 24 hours after the study scan, due to unknown effects of the scan agent on an unborn baby.
  • People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

  • People with serious uncontrolled illnesses, such as an active infection, severe heart failure, unstable chest pain, or an irregular heartbeat.
  • People who have reasons they cannot have a PET/CT scan, including severe claustrophobia (fear of enclosed spaces).
  • People who have previously had an allergic reaction to a drug or substance with a similar make-up to the scan agent used in this study (18F-DCFPyL).
  • People who have any past or current health condition that, in the opinion of the study investigators, could affect the study results or create additional risk by taking part.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Heather Jacene, MD, Dana-Farber Cancer Institute

Phone: 617-632-3767

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 April 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of Participants with PSMA-Positive Lesion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov