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NOT YET RECRUITING
NCT07393867
PHASE2

Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Sponsor: Martin T. King, MD, PhD

View on ClinicalTrials.gov

Summary

This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.

Official title: Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2026-03

Completion Date

2027-12

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

PSMA PET/CT

PSMA PET/CT is an imaging test that uses a radioactive tracer to highlight prostate cancer cells. Imaging will be performed at baseline, approximately eight weeks after starting ADT, and approximately 24 weeks after starting ADT (end of treatment). These scans are used to guide radiation treatment planning and assess treatment response.

DRUG

Androgen Deprivation Therapy (ADT) +/- bicalutamide

ADT is used to lower testosterone levels, which can slow or shrink prostate tumors. All participants will receive approximately six months of ADT starting before radiation therapy, using injectable or oral medications. Depending on the type of ADT, participants may also receive daily bicalutamide. Bicalutamide is categorized as an antiandrogen, which means it will block the effects of testosterone and work together with ADT to slow down or shrink prostate cancer.

RADIATION

Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost

SBRT is a form of radiation therapy that delivers precise, high-dose radiation to the prostate over a short period of time. SBRT will be initiated 10 weeks after initiation of ADT and will be delivered in five sessions over two weeks. Based on PSMA PET/CT and MRI findings after initiation of ADT, some participants may receive an optional focal radiation microboost to areas of residual cancer. The microboost, if delivered, will be given during the same SBRT treatment sessions and will be limited by standard safety constraints.

Locations (4)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center

Milford, Massachusetts, United States

Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital

Weymouth, Massachusetts, United States