Androgen-responsive POSLUMA-guided Intra-prostatic Boost for Prostate Cancer

This study is for men with intermediate- or high-risk prostate cancer who are receiving hormone therapy and radiation. It investigates whether a special imaging test, PSMA PET/CT (an imaging test that uses a radioactive tracer to highlight prostate cancer cells), can help doctors more accurately target remaining cancer with Stereotactic Body Radiation Therapy (SBRT), a precise form of radiation. You would receive standard Androgen Deprivation Therapy (ADT) +/- bicalutamide (hormone therapy to lower testosterone) and SBRT, along with three PSMA PET/CT scans over six months. The main goal is to see how well the PSMA PET/CT imaging helps define the cancer for radiation planning. The study aims to enroll 23 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 23 men. It is not specified if it is randomized or blinded.
What's involved
You would receive approximately six months of ADT, five sessions of SBRT over two weeks, and three PSMA PET/CT scans over a six-month period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 8 weeks from the start of hormone therapy, before radiation begins. Imaging will also be performed at 24 weeks (end of treatment).

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NCT07393867

Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Recruiting
PHASE2Ages 18+InterventionalTreatment
Martin T. King, MD, PhD
~23 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:PSMA PET/CTAndrogen Deprivation Therapy (ADT) +/- bicalutamideStereotactic Body Radiation Therapy (SBRT) +/- focal microboost

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
Measured over 8 weeks from initiation of hormone therapy/before start of radiation therapy
Intermediate Risk Prostate Cancer
High Risk Prostate Cancer
Prostate Cancer
4 sites across 1 states
Massachusetts4

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Eligibility criteria

Inclusion

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

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.
  • Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.8 weeks from initiation of hormone therapy/before start of radiation therapy

    To evaluate whether \>50% of patients will be treated utilizing GTV contours that are highly concordant with those from interim PET/MR scans (GTV-combined-interim) based on the dice coefficient