Not Yet RecruitingPhase 2

Androgen-responsive POSLUMA-guided Intra-prostatic Boost

United States23 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.

Timeframe: 8 weeks from initiation of hormone therapy/before start of radiation therapy

Trial details

NCT IDNCT07393867

SponsorMartin T. King, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12