Recruiting
Phase 2

Hormone Therapy & Radiation

Sponsor:

Martin T. King, MD, PhD

Code:

NCT07393867

Conditions

Intermediate Risk Prostate Cancer

High Risk Prostate Cancer

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PSMA PET/CT

Androgen Deprivation Therapy (ADT) +/- bicalutamide

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

Study Details

Brief 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.

Conditions

Intermediate Risk Prostate Cancer

High Risk Prostate Cancer

Prostate Cancer

Study ID

NCT07393867

Start date

Apr 29, 2026

Status verified date

May, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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.

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.

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 ]

Central Contacts and Locations

Locations

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

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Luke Peng, MD

508-488-3800lcpeng@bwh.harvard.edu

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

Recruiting

Weymouth, Massachusetts, United States, 02190

Contacts

Luke Peng

508-488-3800lcpeng@bwh.harvard.edu

More Information

Sponsor

Martin T. King, MD, PhD

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • POSLUMA
  • prostate-specific membrane antigen positron-emission tomography
  • PSMA-PET/CT
  • 18F-flotufolastat-PSMA-PET/CT scan
  • ADT and 18F-flotufolastat-guided focal SBRT microboost
  • androgen deprivation therapy and 18F-flotufolastat-guided focal SBRT microboost
  • neoadjuvant ADT
  • neoadjuvant androgen deprivation therapy
  • neoadjuvant ADT prior to SBRT
  • 18F-flotufolastat-PET/CT scans for intermediate and high risk prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Martin T. King, MD, PhD on 2026-05-29.