# Radiation Oncology/RTOG Trials/0019

* Front Page: Radiation Oncology | RTOG Trials | Randomized Trials
RTOG 00-19 (PROSTATE)
* Title: A Phase II Study of External Beam Radiation Therapy Combined with Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate
* Objective: The primary goal of this study is to estimate the rate of acute and late Grade 3-5 genitourinary and gastrointestinal toxicity following treatment with external beam radiation therapy and permanent source brachytherapy.
* Protocol: 45 Gy EBRT followed (within 2–6 weeks) by 108 Gy I-125 brachytherapy
* Eligibility:
** cT1c-T2b
** (GS 2-6 and PSA 10–20) or (GS 7 and PSA <20)
** N0M0
** TRUS volume <60cc
* Enrolled: 138 patients
* Activation: November 13, 2000
* Closed: November 30, 2001
* Additional Info: January 2002 Meeting Minutes -- "A Phase II study of external beam radiation therapy combined with permanent source brachytherapy for intermediate risk clinically localized adenocarcinoma of the prostate. This protocol closed November 2001 having accrued 116 patients in approximately one year’s time. There is no mature data yet available regarding toxicity. Dr. Robert Lee presented the preliminary quality assurance data that suggests a lack of conformity between radiation oncologists in defining prostate volumes. There is a direct correlation between nonconformity in defining prostate volumes and nonconformity in dose delivered. Considerable discussion ensued regarding how to manage this problem within future RTOG prostate brachytherapy protocols. Suggestions to be taken to the Image Guided Radiotherapy Committee are having a central rapid-review system in place (not likely practical), or to have a web-based case illustrating how the volumes are to be drawn."
* Publications:
** PMID 17340591, 2007 -- "Late toxicity and biochemical recurrence after external-beam radiotherapy combined with permanent-source prostate brachytherapy: analysis of Radiation Therapy Oncology Group study 0019." (Lee WR, Cancer. 2007 Apr 15;109(8):1506-12.)
*** Conclusion: The morbidity observed in this multiinstitutional, cooperative group study was slightly higher than that reported in recent RTOG studies using brachytherapy alone or high-dose external-beam radiotherapy. The BR rate observed in this report was similar to that observed with high-dose external-beam radiotherapy alone in similar patients.
** PMID 17118317, 2006 — "A descriptive analysis of postimplant dosimetric parameters from Radiation Therapy Oncology Group P0019. Lee WR et al. Brachytherapy. 2006 Oct-Dec;5(4):239-43.
*** Dosimetric parameters (D90, V100, V150, V200) in this study were similar to those in previous studies.
** PMID 16289906, 2006 — A phase II study of external beam radiotherapy combined with permanent source brachytherapy for intermediate-risk, clinically localized adenocarcinoma of the prostate: Preliminary results of RTOG P-0019. Lee WR et al. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):804-9.
*** Median f/u 20 mos. Acute grade 3 genitourinary toxicity in 7.6%. No grade 4 or 5. Late grade 3 GU and GI toxicity was 3.3% at 18 mos. No grade 4 or 5.
** ASCO Abstract - Is postimplant dosimetry associated with late morbidity? A secondary analysis of RTOG P-0019 (Lee W, ASCO 2005). Conclusion: The calculated D80 in this multi-institutional trial is consistent with reports from single institutions. There is no evidence of a relationship between D80 and the development of late morbidity in this trial.
** ASCO Abstract - A phase II study of external beam radiation therapy combined with permanent source brachytherapy for intermediate risk clinically localized adenocarcinoma of the prostate: Preliminary results of RTOG P-0019. (Lee WR, ASCO 2004). Conclusion: The acute and late morbidity observed in this multi-institutional, cooperative group study is consistent with previous reports from single institutions with significant prostate brachytherapy experience. The combination of external beam radiation therapy and permanent source brachytherapy is worthy of further study and is currently under evaluation in RTOG 0232, a phase III trial that compares permanent source brachytherapy as monotherapy to the combination of external beam treatment followed by brachytherapy.