Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Conditions

• High Risk Prostate Cancer
• Intermediate Risk Prostate Cancer
• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PSMA PET/CT — DIAGNOSTIC_TEST
  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.
• Androgen Deprivation Therapy (ADT) +/- bicalutamide — DRUG
  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.
• Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost — RADIATION
  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.

Study Details

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 Dates

Start date

Apr 29, 2026

Status verified

May 2026

Primary completion

Dec 15, 2026

Completion

Dec 15, 2027

Study Design

Enrollment

23 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ADT + SBRT + PSMA PET/CT Imaging
  * ADT as prescribed * PSMA PET/CT imaging will be completed at baseline, 8 weeks after ADT start, and at end of treatment * SBRT is administered starting 10 weeks after ADT start

Primary Outcome Measure

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

Locations (4)

Find similar trials in Boston, MA

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