Actively Recruiting
Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO) for Intermediate- and High-Risk Prostate Cancer
Led by Martin T. King, MD, PhD · Updated on 2026-05-29
23
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Martin T. King, MD, PhD
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging approach for men with intermediate- or high-risk prostate cancer who plan to receive hormone therapy and radiation treatment. The study aims to see if using a special imaging test during hormone therapy can help doctors better identify where active cancer remains in the prostate. This could allow for more precise radiation targeting, potentially reducing side effects by avoiding unnecessary treatment to healthy areas. All participants will receive standard hormone therapy (androgen deprivation therapy or ADT) for about six months, combined with stereotactic body radiation therapy (SBRT) beginning around 10 weeks after starting ADT. Three PSMA PET/CT scans and MRI scans will be performed: before hormone therapy begins, about eight weeks after ADT starts (before radiation planning), and at 24 weeks (end of treatment). Based on these scans, some patients may receive an extra focused radiation boost to areas where active cancer remains, while others may not need this boost if the cancer has responded well. Participants will be monitored with imaging, blood tests measuring PSA levels, and patient-reported quality of life questionnaires focusing on urinary, bowel, and sexual symptoms. Researchers will assess how well the imaging guides radiation planning and treatment targeting. The total participation lasts about six months, during which standard treatments are combined with experimental imaging to improve radiation precision and reduce side effects for future patients.
CONDITIONS
Brief Title
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 18 years of age or older
- Eastern Oncology Group Status 0 to 1
- Histologic diagnosis of prostate cancer
- Prior screening MRI within 180 days showing at least one PI-RADS 4 or 5 lesion
- NCCN intermediate-risk or high-risk prostate cancer confirmed by MRI
- Prior PSMA PET scan within 180 days showing at least one focal avid lesion matching MRI
- Planned stereotactic body radiation therapy (SBRT) with focal boost to one MRI/PET-concordant lesion
You will not qualify if you...
- Prior imaging showing nodal or distant disease
- Planned treatment intensification with secondary androgen receptor inhibitors or chemotherapy
- Clinical T4 disease
- Prior androgen deprivation therapy
- Prior pelvic radiation therapy
- Prior prostate surgery including TURP
- International prostate symptom score greater than 20
- Prior urethral stricture
- Prostate volume greater than 80 cc on MRI
- Hip implants causing artifacts over the prostate
- Unable to stop anti-coagulation for fiducial marker placement
- Active Crohn's disease or scleroderma
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive approximately six months of hormone therapy to lower testosterone levels before and during radiation therapy.
Visits for injections or medication as prescribed
Duration - Throughout the 6-month study period
Participants undergo PSMA PET/CT and MRI scans at baseline, about 8 weeks after starting ADT, and at 24 weeks to guide radiation planning and assess treatment response.
3 imaging visits (in-person)
Duration - 5 sessions over 2 weeks
Participants receive precise high-dose radiation over about two weeks starting 10 weeks after ADT initiation. Some may receive additional targeted radiation to areas showing active cancer based on imaging results.
5 visits (in-person) for radiation treatment
Trial Site Locations
Total: 4 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
3
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, United States, 01757
Actively Recruiting
4
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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