Prospective Phase 2 Trial: Long-term results of a salvage brachytherapy combined with interstitial hyperthermia as Re-Irradiation for locally recurrent prostate Carcinoma
Abstract
Purpose: This prospective Phase 2 trial investigates efficacy and side effects of ultrasound-guided salvage brachytherapy with interstitial hyperthermia in locally recurrent prostate cancer following previous radiation therapy.
Materials and methods: Altogether 109 patients with locally recurrent prostate cancer after previous external beam radiation therapy were enrolled in this Phase 2, multicentric prospective trial between 2015 and 2020. Patients received either 30 Gy in three fractions 21 days apart (78.0 Gy, EQD2, α/ β = 3 Gy) using interstitial HDR-brachytherapy alone or 60 Gy in 2 sessions 28 days apart (71.5 Gy (EQD2, α/β = 3 Gy) using interstitial PDR-brachytherapy alone. We performed the interstitial brachytherapy in all patients with plastic needles. Additionally, interstitial hyperthermia treatment was executed within one hour before or during every brachytherapy fraction/series for a therapeutic time of 60 min and a target temperature of 40-41 °C, at least. The primary endpoint of this prospective phase 2 trial was rate of late Grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) side effects. Treatment-related toxicity was evaluated according to the Common Toxicity Criteria for Adverse Events version 4.03 (CTCAE). Secondary endpoints were cumulative local recurrence rate, biochemical disease-free survival (bDFS), overall survival (OS), disease-free survival (DFS) and cancer-specific survival. This trial is registered with ClinicalTrials.gov number…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 109 participants or records.
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.