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Recruiting NCT05667636

Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Conditions: Prostatic Neoplasm

Sex: Male
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 103
Sponsor: Regina Elena Cancer Institute

Location: Italy

Summary

After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

Eligibility Criteria

Inclusion Criteria:- Able and willing to provide informed consent;Pathologically proven diagnosis of prostatic adenocarcinoma;Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;No regional or distant metastases;Eastern Cooperative Oncology Group performance status 0-1Exclusion Criteria:- Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;Previous radiotherapy to the pelvis;Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);PSA level at sRT> 2 ng/ml;(Each single) Lesion volume within the prostatic fossa at mpMR >5 cc;Previous chemotherapy for malignancy in past 5 years;Previous androgen deprivation for biochemical failure after RP;Contraindication to short term AD (in case of Px)Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CTPathologically positive lymph nodes (pN+) at RP;Serious medical comorbidities or other contraindications to radiotherapyPresence of active inflammatory bowel disease;Presence of active connective tissue disease;Unable or unwilling to complete quality of life questionnaires

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05667636). StuddyBuddy aggregates publicly available trial information.