Prospective Phase 2 Trial of Permanent Seed Implantation Prostate Brachytherapy for Intermediate-Risk Localized Prostate Cancer: Efficacy, Toxicity, and Quality of Life Outcomes

Frank, Steven J.; Pugh, Thomas J.; Blanchard, Pierre; Mahmood, Usama; Graber, William; Kudchadker, Rajat J.; Davis, John W.; Kim, Jeri; Choi, Haesun; Troncoso, Patricia; Kuban, Deborah A.; Choi, Seungtaek; McGuire, Sean E.; Hoffman, Karen E.; Chen, Hsiang Chun; Wang, Xuemei; Swanson, David A.

doi:10.1016/j.ijrobp.2017.09.050

Cited by 46 publications

(25 citation statements)

References 45 publications

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“…Overall, there was a low incidence of acute and late urinary and gastro-intestinal toxicity combined with excellent oncological results. These results are in concordance with the experience of other institutions [12,13,14,15,16,17] and results seen in a non-TURP population [18,19,20,21,22,23].…”

Section: Discussionsupporting

confidence: 92%

A history of transurethral resection of the prostate should not be a contra-indication for low-dose-rate 125I prostate brachytherapy: results of a prospective Uro-GEC phase-II trial

Salembier¹,

Henry²,

Pieters³

et al. 2020

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Purpose: Early reports suggested that transurethral resection (TURP) prior to permanent seed brachytherapy (BT) results in high incontinence rates. Guidelines consider prior TURP as a contra-indication to treatment, but improvements in imaging and treatment planning may reduce this risk, and are investigated in this prospective study. Material and methods: 99 men with histologically proven low-to intermediate-risk, localized prostate cancer, with a history of TURP performed at least 3 months before BT procedure were enrolled. All patients received a permanent seed implant between March 2009 and June 2015. Intra-operative interactive planning was recommended to ensure optimal accuracy of seed placement during the procedure. No supplemental external beam was allowed. Target and organ at risk contouring, definition of clinical target volume (CTV), and dosimetric parameters followed the modified GEC-ESTRO guidelines for permanent seed implants, as described an earlier report of our group. Follow-up was scheduled every 3 months for the first year, and every 6 months afterwards, with minimum follow-up of 2 years. Study endpoints: The primary endpoint was the incidence of post-implant urinary incontinence. Secondary endpoints were the incidence of urinary and gastro-intestinal toxicity, the eventual impact on the sexual function, and the freedom from biochemical failure. Results: The median follow-up time for these 99 patients was 49 months (min. 24, max. 96). In this series, the incontinence rate was 2% after TURP + BT and 2% in case of TURP + BT + re-TURP, ending up with a total urinary incontinence rate of 4%. Acute and late urinary toxicities were extremely low. No significant late gastro-intestinal toxicity was seen, and the 5-year biochemical non-evidence of disease (bNED) was 93%. Conclusions: The excellent long-term results and low morbidity presented as well as many advantages of prostate brachytherapy over other treatments demonstrates that brachytherapy is an effective treatment for patients with transurethral resection and organ-confined prostate cancer.

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Section: Discussionsupporting

confidence: 92%

A history of transurethral resection of the prostate should not be a contra-indication for low-dose-rate 125I prostate brachytherapy: results of a prospective Uro-GEC phase-II trial

Salembier¹,

Henry²,

Pieters³

et al. 2020

jcb

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“…To place the results of the present series in the appropriate context, we extracted the rates of late severe (ie, grade ≥3) toxic events after treatment with other radiotherapy modalities from prospective reports with long-term follow-up for each of the other modalities ( Figure 2 ). 4 , 5 , 6 , 35 , 36 , 37 , 38 , 39 , 40 , 41 Further information about these series can be found in eTable 9 in the Supplement . Overall, the outcomes after SBRT compare very favorably, without evidence of unanticipated late failures or increased late toxic effects.…”

Section: Discussionmentioning

confidence: 99%

Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer

et al. 2019

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Importance Stereotactic body radiotherapy harnesses improvements in technology to allow the completion of a course of external beam radiotherapy treatment for prostate cancer in the span of 4 to 5 treatment sessions. Although mounting short-term data support this approach, long-term outcomes have been sparsely reported. Objective To assess long-term outcomes after stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer. Design, Setting, and Participants This cohort study analyzed individual patient data from 2142 men enrolled in 10 single-institution phase 2 trials and 2 multi-institutional phase 2 trials of stereotactic body radiotherapy for low-risk and intermediate-risk prostate cancer between January 1, 2000, and December 31, 2012. Statistical analysis was performed based on follow-up from January 1, 2013, to May 1, 2018. Main Outcomes and Measures The cumulative incidence of biochemical recurrence was estimated using a competing risk framework. Physician-scored genitourinary and gastrointestinal toxic event outcomes were defined per each individual study, generally by Radiation Therapy Oncology Group or Common Terminology Criteria for Adverse Events scoring systems. After central review, cumulative incidences of late grade 3 or higher toxic events were estimated using a Kaplan-Meier method. Results A total of 2142 men (mean [SD] age, 67.9 [9.5] years) were eligible for analysis, of whom 1185 (55.3%) had low-risk disease, 692 (32.3%) had favorable intermediate-risk disease, and 265 (12.4%) had unfavorable intermediate-risk disease. The median follow-up period was 6.9 years (interquartile range, 4.9-8.1 years). Seven-year cumulative rates of biochemical recurrence were 4.5% (95% CI, 3.2%-5.8%) for low-risk disease, 8.6% (95% CI, 6.2%-11.0%) for favorable intermediate-risk disease, 14.9% (95% CI, 9.5%-20.2%) for unfavorable intermediate-risk disease, and 10.2% (95% CI, 8.0%-12.5%) for all intermediate-risk disease. The crude incidence of acute grade 3 or higher genitourinary toxic events was 0.60% (n = 13) and of gastrointestinal toxic events was 0.09% (n = 2), and the 7-year cumulative incidence of late grade 3 or higher genitourinary toxic events was 2.4% (95% CI, 1.8%-3.2%) and of late grade 3 or higher gastrointestinal toxic events was 0.4% (95% CI, 0.2%-0.8%). Conclusions and Relevance In this study, stereotactic body radiotherapy for low-risk and intermediate-risk disease was associated with low rates of severe toxic events and high rates of biochemical control. These data suggest that stereotactic body radiotherapy is an appropriate definitive treatment modality for low-risk and intermediate-risk prostate cancer.

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“…R 2 was evaluated for goodness-of-fit. The resulting monotherapy nomograms were compared with historic transrectal ultrasound (TRUS)ebased nomograms from our recently published phase II trial (n 5 300) by using an F test (10). In addition, we evaluated V100 and D90 between planned and Day 0 dosimetry for patients treated with MARS.…”

Section: Methodsmentioning

confidence: 99%

MRI-assisted radiosurgery: A quality assurance nomogram for palladium-103 and iodine-125 prostate brachytherapy

et al. 2020

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We sought to develop an activity nomogram for magnetic resonance (MR)eplanned permanent seed prostate brachytherapy to improve quality assurance through a secondary dosimetric check. METHODS AND MATERIALS: Patients undergoing MRI-assisted radiosurgery (MARS), whereby MRI is used for preoperative planning and postimplant dosimetry, were reviewed from May 2016 to September 2018. Planned activity (U) was fitted by MR-prostate volume (cc) via simple linear regression. Resulting monotherapy nomograms were compared with institutional nomograms from an ultrasound-planned cohort. Dosimetric coverage and external urinary sphincter (EUS) dose were also assessed for MR-planned patients. RESULTS: We identified 183 patients treated with MARS: 146 patients received palladium-103 (103 Pd; 102 monotherapy and 44 boost), and 37 received iodine-125 (125 I) monotherapy. Median prostate volume was 28 cc (interquartile range: 22e35). Lines of best fit for implant activity were U 5 4.344 Â (vol) þ 54.13 (R 2 : 95%) for 103 Pd monotherapy, U 5 3.202 (vol) þ 39.72 (R 2 : 96%) for 103 Pd boost and U 5 0.684 (vol) þ 13.38 (R 2 : 96%) for 125 I monotherapy. Compared with ultrasound, MR-planned nomograms had lower activity per volume (p ! 0.05) for both 103 Pd monotherapy (~6%) and 125 I monotherapy (~11%), given a median size (30 cc) prostate. Across all MARS implants, postimplant dosimetry revealed a median V100% of 94% (interquartile range: 92e96%). Median EUS V125 was !1 cc for all patients, regardless of isotope. CONCLUSIONS: We developed a quality assurance nomogram for MR-planned prostate brachytherapy. When compared with ultrasound-planned, MR-planned monotherapy resulted in a lower activity-to-volume ratio while maintaining dosimetric coverage, likely secondary to EUS-sparing and reduced planning target margins.

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Prospective Phase 2 Trial of Permanent Seed Implantation Prostate Brachytherapy for Intermediate-Risk Localized Prostate Cancer: Efficacy, Toxicity, and Quality of Life Outcomes

Abstract: Brachytherapy monotherapy is safe and effective and leads to good quality of life for some men with localized intermediate-risk prostate cancer.

Cited by 46 publications

References 45 publications

A history of transurethral resection of the prostate should not be a contra-indication for low-dose-rate 125I prostate brachytherapy: results of a prospective Uro-GEC phase-II trial

A history of transurethral resection of the prostate should not be a contra-indication for low-dose-rate 125I prostate brachytherapy: results of a prospective Uro-GEC phase-II trial

Long-term Outcomes of Stereotactic Body Radiotherapy for Low-Risk and Intermediate-Risk Prostate Cancer

MRI-assisted radiosurgery: A quality assurance nomogram for palladium-103 and iodine-125 prostate brachytherapy

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