Androgen-guided PSMA-PET-boost for prostate cancer treated with ADT and SBRT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial is a Phase 2 interventional study in men with intermediate- or high-risk prostate cancer planned for androgen deprivation therapy (ADT) and radiation. Participants undergo PSMA PET/CT and MRI at three time points: before starting ADT, about eight weeks after starting ADT (before planning SBRT), and at 24 weeks to assess response. All participants receive standard ADT and SBRT, with an option for a focal microboost to MRI/PET-concordant lesions based on imaging results. The goal is to determine if PSMA-PET imaging during ADT improves targeting of active cancer while reducing radiation to unaffected tissue. Outcomes will inform whether this imaging-guided approach can make prostate radiation more precise and potentially lessen side effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
  Milford, Massachusetts, United States Recruiting
• Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
  Weymouth, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Not yet recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.