Androgen-responsive POSLUMA-guided Intra-prostatic Boost
Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)
Martin T. King, MD, PhD
23 participants
Apr 29, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria12
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
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.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07393867