Clinical trial · Interventional
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Prostate Cancer | — | UNRESOLVED | — |
| Intermediate Risk Prostate Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy (ADT) +/- bicalutamide | Drug | — | UNRESOLVED |
| PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADT + SBRT + PSMA PET/CT Imaging
- description
- * 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
- interventionNames
- Diagnostic Test: PSMA PET/CT
- Drug: Androgen Deprivation Therapy (ADT) +/- bicalutamide
- Radiation: Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
Primary outcomes (1)
- measure
- Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
- timeFrame
- 8 weeks from initiation of hormone therapy/before start of radiation therapy
- description
- 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
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available