NCT07393867|RecruitingPhase 2DMCFDA Drug
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
ARPEGGIO
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Sponsor study identifier
interventional
23
1 country
4
Study Start
April 29, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2026
Actual (reported)February 6, 2026
Actual (reported)April 29, 2026
Actual (reported)December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
To evaluate whether \>50% of patients will be treated utilizing GTV contours that are highly concordant with those from interim PET/MR scans (GTV-combined-interim) based on the dice coefficient
8 weeks from initiation of hormone therapy/before start of radiation therapy
Geometric accuracies of GTV-Combined-Baseline and GTV-combined-interim contours
8 weeks from initiation of hormone therapy/before start of radiation therapy
PSA response
8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
* 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
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.
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
First Submitted
January 27, 2026
First Posted
February 6, 2026
Study Start
April 29, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedPSMA PET response
8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
MRI ADC contrast ratio
8 weeks from initiation of hormone therapy
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
Weymouth, Massachusetts, 02190, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 29, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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