由于分子PET/CT成像技术在生化复发工作中的应用，肝内前列腺局部放射性再发 (LRR) 越来越常见。根据早期的研究序列，挽救性高剂量率 (HDR) 具有良好的局部治疗效果和可行性，并且通过先进成像技术的应用，可使局部HDR进一步降低毒性，最大限度地提高治疗比率。F-SHARP的目标是确定局部挽救性HDR内放疗治疗LRR前列腺癌的急性和远期毒性和疗效结果。F-SHARP是挽救性HDR内放疗治疗LRR前列腺癌的多中心二阶段I/II临床试验，旨在招募3个中心的患者。主要终点是与内放疗后3个月内的急性放射性相关的CTCAE v4.03 GU和GI等级≥3毒性率。次要终点包括急性和远期CTCAE v4.03毒性、生化失败、临床进展模式、疾病特异性和总体生存率以及通过IPSS和EPIC-26工具测量的与健康相关的生活质量。主要参与资格标准包括：经活检证实的在任何放射治疗模式之后的LRR前列腺腺癌，无局部或远处转移证据，及初次治疗时cT1-3a Nx或N0前列腺癌。所有患者将进行多参数MRI和分子PET成像（如果可能）。在第一阶段，将招募7名患者。如果出现≥2例GI或GU等级≥3的毒性，研究将停止。否则，将再招募17名患者（总计24名患者）。在第二阶段，队列将扩大到62名患者，以研究疗效结果、长期毒性情况、生活质量，并比较单次和多次剂量的HDR。将对再发活检进行转录组分析，以确定潜在的预后和预测性生物标志物。NCT03312972.© 2023 BJU International.

Intraprostatic local radiorecurrence (LRR) after definitive radiation is being increasingly identified due to the implementation of molecular PET/CT imaging into workup for biochemical recurrence. Salvage high dose rate (HDR) brachytherapy offers a promising local therapy option, with encouraging toxicity and efficacy based on early series. Furthermore, the incorporation of advanced imaging allows for focal HDR to further reduce toxicity to maximize the therapeutic ratio. The objectives of F-SHARP are to determine the acute and late toxicity and efficacy outcomes of focal salvage HDR brachytherapy for LRR prostate cancer.F-SHARP is a multi-institutional two-stage phase I/II clinical trial of salvage focal HDR brachytherapy for LRR prostate cancer enrolling patients at 3 centers.The primary endpoint is the acute radiation-related grade ≥3 CTCAE v4.03 GU and GI toxicity rate, defined as within 3 months of brachytherapy. Secondary endpoints include acute and late CTCAE v4.03 toxicity, biochemical failure, patterns of clinical progression, disease-specific and overall survival, and health-related quality of life, as measured by the IPSS and EPIC-26 instruments.Key eligibility criteria include: biopsy-proven LRR prostate adenocarcinoma after prior definitive radiation therapy using any radiotherapeutic modality, no evidence of regional or distant metastasis, and cT1-3a Nx or N0 prostate cancer at initial treatment. All patients will have multiparametric MRI and molecular PET imaging if possible. In Stage 1, 7 patients will be accrued. If there are ≥2 GI or GU grade ≥3 toxicities, the study will be stopped. Otherwise, 17 additional patients will be accrued (total of 24 patients). For Stage 2, the cohort will expand to 62 subjects to study the efficacy outcomes, long-term toxicity profile, quality of life, and compare single vs. multi-fraction HDR. Transcriptomic analysis of recurrence biopsies will be performed to identify potential prognostic and predictive biomarkers.NCT03312972.© 2023 BJU International.