Prostate Cancer Clinical Trials

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Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation, Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Dana Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
RECRUITING
Milford
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
RECRUITING
Weymouth
Time Frame
Start Date: 2026-04-29
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 23
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Blue Earth Diagnostics, Dana-Farber/Brigham and Women's Cancer Center
Leads: Martin T. King, MD, PhD

This content was sourced from clinicaltrials.gov