A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Womens Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Heather Jacene, MD
hjacene@partners.org
617-632-3767
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Progenics Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov