Outcomes of a Phase II Interventional Clinical Trial of Prostate Bed Stereotactic Body Radiation Therapy for Prostate Cancer With High-Risk Features Following Radical Prostatectomy
Abstract
Purpose: This study reports the safety and efficacy outcomes of a phase II prospective trial evaluating stereotactic body radiation therapy (SBRT) to the prostate bed in patients with high-risk features following radical prostatectomy.
Methods and materials: Between May 2018 and May 2020, 49 patients were enrolled and stratified into 3 groups based on clinical context: group I (adjuvant SBRT, PSA < 0.2 ng/mL with adverse features such as positive margins, seminal vesicle invasion (SVI), or extraprostatic extension), group II (salvage SBRT, PSA ≥ 0.2 and <2.0 ng/mL), and group III (oligometastatic disease, ≤5 sites). Patients with PSA ≥ 0.2 ng/mL underwent staging with C11 positron emission tomography (PET); those with biochemical failure following treatment were restaged with PSMA PET. All patients received SBRT to the prostate bed to a total dose of 30 to 32 Gy in 5 fractions administered every other day. Patients in the salvage and oligometastatic groups received 6 and 18 months of androgen deprivation therapy (ADT), respectively. The primary endpoint was freedom from failure (FFF), defined as a PSA < 0.5 ng/mL without clinical progression or reinitiation of ADT. Secondary endpoints included FFF with a PSA < 0.2 ng/mL, toxicity rates (graded per CTCAE v5.0), clinical failure, and FFF in early salvage patients (PSA 0.2 to <0.5 ng/mL).
Results: The median follow-up was 60 months. High-risk features included extraprostatic extension in 49%, SVI in 10%, positive margins in…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
Read the paper
Related studies
- Preliminary Toxicity Analysis of 3DCRT versus IMRT on the High Dose Arm of the RTOG 0126 Prostate Cancer Trial
- Adaptive Radiotherapy for Head and Neck Cancer: Initial Clinical Outcomes from a Prospective Trial
- American Association of Physicists in Medicine Task Group 263: Standardizing Nomenclatures in Radiation Oncology
- Motion Management Strategies and Technical Issues Associated with Stereotactic Body Radiotherapy of Thoracic and Upper Abdominal Tumors: A Review from NRG Oncology
- High-dose-rate interstitial brachytherapy as a monotherapy for localized prostate cancer: treatment description and preliminary results of a phase I/II clinical trial
- Highly efficient training, refinement, and validation of a knowledge-based plan quality control system for radiotherapy clinical trials
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.