Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Recruiting now · Phase 2

Conditions studied: Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07393867

Run by

Martin T. King, MD, PhD

People needed

23

Starts

2026-04-29

Expected to finish

2027-12-15

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age and older.
• Eastern Oncology Group Status 0 to 1.
• Histologic diagnosis of prostate cancer.
• Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
• NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
• Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.
• Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34.

You may not qualify if…

• Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
• Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
• Clinical T4 disease.
• Prior ADT.
• Prior pelvic RT.
• Prior prostate surgery, including TURP.
• International prostate symptom score > 20.
• Prior urethral stricture.
• Prostate volume > 80 cc on MRI.
• Hip implants that cause artifacts over the prostate gland.
• Inability to discontinue anti-coagulation for fiducial marker placement.
• Active Crohn's disease or scleroderma.

Where it is running

• Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center — Milford, Massachusetts, United States (enrolling)
• Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital — Weymouth, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.