A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer after External Beam Radiation Therapy (NRG/RTOG0526): Initial Report of Late Toxicity Outcome

Crook, Juanita; Zhang, P.; Pisansky, Thomas M.; Amin, Mahul B.; Bice, William S.; Morton, Gerard; Catton, Charles; Michalski, Jeff M.; Roach, Mack; Beyer, Diana; Horwitz, Eric M.; Rossi, Peter J.; Vigneault, Éric; Trabulsi, E.; Pervez, N.; Donavanik, Viroon; Sandler, Howard M.

doi:10.1016/j.ijrobp.2017.06.020

Cited by 6 publications

(3 citation statements)

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“…Grade 3 urinary and rectal toxicity has been reported in up to 30% and 20% of cases, respectively. The rate of grade 3 late urinary toxicity following salvage whole gland LDR was 14% in the RTOG 0526 clinical trial ( 72 ).…”

Section: Rationalementioning

confidence: 99%

High dose-rate brachytherapy in the treatment of prostate cancer

Mendez

Morton

2018

Transl. Androl. Urol.

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High dose-rate (HDR) brachytherapy involves delivery of a high dose of radiation to the cancer with great sparing of surrounding organs at risk. Prostate cancer is thought to be particularly sensitive to radiation delivered at high dose-rate or at high dose per fraction. The rapid delivery and high conformality of dose results in lower toxicity than that seen with low dose-rate (LDR) implants. HDR combined with external beam radiotherapy results in higher cancer control rate than external beam only, and should be offered to eligible high and intermediate risk patients. While a variety of dose and fractionations have been used, a single 15 Gy HDR combined with 40–50 Gy external beam radiotherapy results in a disease-free survival of over 90% for intermediate risk and 80% for high risk. HDR monotherapy in two or more fractions (e.g., 27 Gy in 2 fractions or 34.5 Gy in 3) is emerging as a viable alternative to LDR brachytherapy for low and low-intermediate risk patients, and has less toxicity. The role of single fraction monotherapy to a dose of 19–20 Gy is evolving, with some conflicting data to date. HDR should also be considered as a salvage approach for recurrent disease following previous external beam radiotherapy. A particular advantage of HDR in this setting is the ease of delivering focal treatments, which combined with modern imaging allows focal dose escalation with minimal toxicity. Trans-rectal ultrasound (TRUS) based planning is replacing CT-based planning as the technique of choice as it minimizes or eliminates the need to move the patient between insertion, planning and treatment delivery, thus ensuring high accuracy and reproducibility of treatment.

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Section: Rationalementioning

confidence: 99%

High dose-rate brachytherapy in the treatment of prostate cancer

Mendez

Morton

2018

Transl. Androl. Urol.

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“…For salvage RT in the NRG02526 trial, Crook et al. 30 observed a 14% crude rate of grade 3 toxicity at a median follow up of 54 months, which is below the 20% rate that is considered unacceptable. However, in this trial, reirradiation was performed using permanent seed BT, a technique known to minimize reirradiation of the rectal wall.…”

Section: Discussionmentioning

confidence: 97%

Salvage reirradiation for local failure of prostate cancer after curative radiation therapy: Association of rectal toxicity with dose distribution and normal-tissue complication probability models

Dipasquale

Zilli

Fiorino

et al. 2018

Advances in Radiation Oncology

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PurposeThis study aimed to assess the impact of radiation dose on rectal toxicity after salvage external beam radiation therapy (EBRT) with or without a brachytherapy boost for exclusive local failures after the primary EBRT for prostate cancer.Methods and materialsFourteen patients with no severe residual late toxicity after primary EBRT ± brachytherapy were reirradiated after a median time interval of 6.1 years. The median normalized total dose in 2 Gy fractions (NTD2Gy, α/β ratio = 1.5 Gy for prostate cancer cells) was 74 Gy at primary EBRT and 85.1 Gy at reirradiation. Rectal dose-volume histograms (converted to NTD2Gy_alpha/beta = 3 Gy) and the corresponding normal-tissue complication probability (NTCP) values for gastrointestinal (GI) toxicity were evaluated for 2 groups: High GI toxicity (grade ≥3) and low GI toxicity (grade ≤2).ResultsThe 5-year grade ≥3 GI toxicity-free survival rate was 57.1%. The median rectal V70Gy and maximum dose to 1 cm3 (D1ccrect) at primary EBRT were both predictive for grade ≥3 GI toxicity (9% vs 0%; P = .04 and 72.2 Gy vs 66.8 Gy; P < .01, respectively). When adding primary radiation therapy (RT) and reirradiation plans, the median D1ccrect was 139.8 Gy versus 126.7 Gy (P < .01) for high and low GI toxicity groups. NTCP >10% at primary RT was predictive for high GI toxicity at reirradiation (P < .05).ConclusionsEven in the absence of residual toxicity after primary RT, rectal doses >70 Gy and NTCP >10% calculated for a first irradiation may be associated with a higher risk of developing high GI toxicity at reirradiation with a possible D1ccrect threshold of 130 Gy.

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“…This rate of late grade 3 toxicity (14%) was not unacceptable by the predetermined protocol specification, without any grade 4–5 events. The only factor predictive of late toxicity was implant dose, underlining the need for meticulous planning and technique to limit the final delivered dose 12. In France, a phase II study, ‘Brachytherapy for Recurrent Prostate Cancer’ (CAPRICUR) was recently completed 13…”

Section: Introductionmentioning

confidence: 99%

GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy—study protocol

et al. 2019

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IntroductionProstate cancer is the third most important cancer in terms of mortality in men. No standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. Stereotatic body radiotherapy (SBRT) could be a curative treatment for local recurrence. The phase I/II primary objective is the selection of the recommended dose for salvage-SBRT and to estimate the efficacy.Methods and analysisWe plan to perform a multicentre prospective phase I/II study including at least 47 patients. Eligible patients are patients with biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (prostate-specific antigen (PSA) nadir +2 ng/mL) and histologically proven intraprostatic recurrence only (stage T1-T2 on relapse, PSA level ≤10 ng/mL, PSA doubling time >10 months, absence of pelvic or metastatic recurrence proven by choline or PSMA positron emission tomography scan, and pelvic and prostatic assessment by multiparametric MRI). The phase I primary objective is the selection of the recommended dose for salvage-SBRT (5×6, 6×6 or 5×5 Gy) based on dose-limiting toxicity (DLT). The dose of salvage-SBRT will be selected using a time-to-event continual reassessment method based on DLT defined as grade ≥3 gastrointestinal or urinary toxicity or any other grade 4 adverse event. The phase II primary outcome is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate (Phoenix definition: increase in serum total PSA ≥2 ng/mL above the nadir). Phase II secondary outcomes are acute and late toxicities, quality of life, clinical progression-free survival defined as the time interval between the date of registration and the date of clinical progression or death irrespective of the cause.Ethics and disseminationThe study has received ethical approval from the Ethics committee ‘Ile-de-France III’. Academic dissemination will occur through publication and conference presentations.Trial registration numberNCT03438552

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A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer after External Beam Radiation Therapy (NRG/RTOG0526): Initial Report of Late Toxicity Outcome

Cited by 6 publications

References 0 publications

High dose-rate brachytherapy in the treatment of prostate cancer

High dose-rate brachytherapy in the treatment of prostate cancer

Salvage reirradiation for local failure of prostate cancer after curative radiation therapy: Association of rectal toxicity with dose distribution and normal-tissue complication probability models

GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy—study protocol

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