Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

Study Overview
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Brief Summary
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This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.

Official Title
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Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Image-guided Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men older than 18 years old. Histologically proven initial diagnosis of adenocarcinoma prostate cancer. Previous radical prostatectomy. Biochemical relapse with local or regional recurrence proven on PSMA PET. Five or less positive nodes on the PSMA PET. ECOG 0-1 Exclusion Criteria: Presence of para-aortic lymph nodes or distant metastasis. Chronic pelvic inflammatory disease. Contraindication for radiation treatment. Previous radiation treatment within the pelvis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Molecular Imaging Informed Radiation Dose Escalation and De-escalation<br>Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas. | Radiation: Image-guided Radiotherapy<br>* de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade ≥2 Toxicity for GU | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | Baseline to 5-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Failure Free Survival | Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels | Baseline to 5-year follow-up | 
| Patient-reported quality-of-life assessed by EPIC-26 | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) | Baseline to 5-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, adenocarcinoma, PSMA PET, radical prostatectomy, recurrence