McDonald Andrew M, Dobelbower Michael C, Yang Eddy S, Clark Grant M, Jacob Rojymon, Kim Robert Y, Cardan Rex A, Popple Richard, Nix Jeffrey W, Rais-Bahrami Soroush, Fiveash John B
University of Alabama at Birmingham, Department of Radiation Oncology, Birmingham, Alabama.
East Tennessee Radiation Oncology PC, Knoxville, Tennessee.
Adv Radiat Oncol. 2018 Sep 19;4(1):90-95. doi: 10.1016/j.adro.2018.09.007. eCollection 2019 Jan-Mar.
This study aimed to report the early toxicity results of a prospective clinical trial of prostate stereotactic body radiation therapy (SBRT) to the entire prostate with a simultaneous integrated boost (SIB) to magnetic resonance imaging (MRI)-defined focal lesions.
Eligible patients included men with biopsy-proven prostate stage T1c to T2c adenocarcinoma, a Gleason score ≤7, and prostate-specific antigen values of ≤20 ng/mL, who had at least 1 focal lesion visible on MRI and a total prostate volume no greater than 120 cm. SBRT consisted of a dose of 36.25 Gy to the entire prostate with an SIB of 40 Gy to the MRI-defined lesions, delivered in 5 fractions. The primary purpose of the study was to confirm the feasibility of treatment planning/delivery and to estimate the rate of urinary retention requiring placement of a Foley catheter within 90 days of treatment. This study was to be considered successful if urinary retention occurred in no more than 15% of cases, with a planned enrollment of at least 25 patients.
A total of 26 men were enrolled, and all underwent SBRT as planned. Twenty patients (77%) had intermediate-risk features, and the remainder were low risk. A treatment plan that met the protocol-defined goals for all cases was developed. Two patients (7.7%) developed acute urinary symptoms that required the temporary placement of a Foley catheter. No grade 3+ toxicity events were observed.
Planning and delivery of prostate SBRT with a whole prostate dose of 36.25 Gy and a focal 40 Gy SIB is feasible. Early follow-up suggests that this treatment is not associated with undue morbidity.
本研究旨在报告一项前瞻性临床试验的早期毒性结果,该试验为对整个前列腺进行立体定向体部放射治疗(SBRT),同时对磁共振成像(MRI)定义的局灶性病变进行同步整合加量(SIB)。
符合条件的患者包括经活检证实为前列腺T1c至T2c期腺癌、Gleason评分≤7且前列腺特异性抗原值≤20 ng/mL的男性,这些患者在MRI上至少有1个可见的局灶性病变且前列腺总体积不大于120 cm³。SBRT包括对整个前列腺给予36.25 Gy的剂量,对MRI定义的病变给予40 Gy的SIB,分5次给予。该研究的主要目的是确认治疗计划/实施的可行性,并估计在治疗后90天内需放置Foley导管的尿潴留发生率。如果尿潴留发生率不超过15%,则该研究被认为成功,计划入组至少25例患者。
共纳入26名男性,所有患者均按计划接受了SBRT。20例患者(77%)具有中危特征,其余为低危。制定了一个满足所有病例方案定义目标的治疗计划。2例患者(7.7%)出现急性泌尿系统症状,需要临时放置Foley导管。未观察到3级及以上毒性事件。
全前列腺剂量为36.25 Gy、局灶性40 Gy SIB的前列腺SBRT计划和实施是可行的。早期随访表明,这种治疗不会导致过度的发病率。