Androgen-responsive POSLUMA-guided Intra-prostatic Boost

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMartin T. King, MD, PhD

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

23 Participants
are divided into 1 treatment group

Sponsors and collaborators

Martin T. King, MD, PhD

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Blue Earth Diagnostics

Collaborator

Dana-Farber/Brigham and Women's Cancer Center

Collaborator