Recruiting

18FDCFPyL vs. 68Ga-PSMA-11

Sponsor:

Brigham and Women's Hospital

Code:

NCT06099093

Conditions

Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Metastatic Castration-resistant Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-DCFPyl

Study Details

Brief summary:

The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).

Conditions

Prostate Cancer

Metastatic Castration-resistant Prostate Cancer

Metastatic Castration-resistant Prostate Carcinoma

Study ID

NCT06099093

Start date

Apr 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-DCFPYL-PSMA PET

Study procedures will be conducted as follows:

  • Baseline screening visit with PSMA-PET/CT scan with Ga-PSMA-11.
  • In-clinic visit with exam and PSMA-PET/CT scan with 18F-DCFPyl per standard institutional procedures.
  • Standard of care therapy.
  • Follow up every 3 months via chart review for 12 months, with the purpose of seeing how participants respond to 177Luvipivotide tetraxetan treatment.

Interventions

18F-DCFPyl

Fluorine-labeled small molecule, via intravenous infusion per protocol.

Primary outcome measure

  • Proportion of Participants with PSMA-Positive Lesion [ Time Frame: 1 Day ]

Central Contacts and Locations

Central contacts

Heather Jacene, MD

617-632-3767hjacene@partners.org

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Heather Jacene, MD

617-632-3767hjacene@partners.org

Principal Investigator:

Heather Jacene, MD

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Heather A Jacene, MD

617 632-3767hjacene@partners.org

Principal Investigator:

Heather A Jacene, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 29, 2026

Last verified

Nov, 2025

Keywords

  • Prostate Cancer
  • Metastatic Castration-resistant Prostate Cancer
  • Metastatic Castration-resistant Prostate Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-29.