Radiation Oncology/RTOG Trials/9805

RTOG 98-05 (PROSTATE)
 * Title: A Phase II Trial of Transrectal Ultrasound-Guided Permanent Radioactive Implantation of the Prostate For Definitive Management of Localized Adenocarcinoma of the Prostate
 * Objective: The aim of this study is to evaluate the effectiveness of TRUS permanent implantation of the prostate for organ confined adenocarcinoma of the prostate compared to historical data of prostatectomy or external beam therapy within cooperative group setting.
 * Protocol: 145 Gy I-125 brachytherapy
 * clinicaltrials.gov entry
 * Eligibility: cT1b-T2a and GS <=6 and PSA <=10
 * Enrolled: 95 patients (maximum 6 per institution)
 * Activation: September 8, 1998
 * Closed: April 28, 2000
 * Additional Information:
 * Brachytherapy Meeting Minutes January 2002 - "Acute and late toxicity data is now available. The acute toxicity was primarily grade 1 or 2, with the most common toxicity being related to renal/genitourinary. The late toxicity was primarily grade 1 or 2 bladder toxicity. There were no grade 3 or 4 acute or late toxicities reported. No data was presented regarding freedom from PSA failure."
 * Brachytherapy Meeting Minutes June 2000 - "Dr. Michael Gillin presented an update of this study. The study opened to accrual in September 1998 and closed April 2000 having met its accrual objective of 95 patients. A review of dosimetry quality assurance has begun and should be available for presentation at the next meeting. Dr. Gillin presented some sample cases of the submitted dosimetry to illustrate the quality assurance process. One apparent problem is the observed difference in prostate definition between the treating radiation oncologists and the radiologist undertaking the quality assurance review. The Brachytherapy Committee will recommend that the Research Strategy Committee invite the radiologist to the next RTOG semiannual meeting to discuss this further. High quality assurance scores are critical to successful completion of further prostate brachytherapy studies."
 * Brachytherapy Meeting Minutes January 2000 - "Dr Colleen Lawton presented an update of this study. The study opened to accrual in September 1998 and has accrued 74 patients to date. A review of dosimetry quality assurance has begun and should be available for presentation at the next meeting. Target accrual is 95 patients. The study is accruing well and is expected to close in late 1999. Institutions must undergo a credentialing process prior to accruing patients. Thirty-three institutions have been credentialed but only 18 have put a patient on study. Institutions are encouraged to participate in this study since the credentialing process will be applied to future prostate brachytherapy studies."
 * Conclusion:
 * PMID 17084551 (2007) &mdash; Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (Radiation Therapy Oncology Group 98-05). Lawton CA et al. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):39-47.
 * ASTRO Abstract (2004) -- Results of a Prospective Multi-Institutional Phase II Trial (RTOG 98-05) of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate (Lawton CA, ASTRO 2004). Conclusion: This prospective multi-institutional brachytherapy trial was completed successfully with acceptable quality assurance and early results comparable with single institution series. The toxicities are consistent with other reported series. With this trial, the RTOG has demonstrated its capacity to perform a prospective quality assured prostate brachytherapy trial and provides a positive outlook for the feasibility of subsequent cooperative group trials, including the active Phase III trial RTOG P-0232 examining the role of supplemental external beam radiotherapy for prostate brachytherapy.
 * Publications:
 * PMID 16864066 (2006) -- Quality assurance methods for the first Radiation Therapy Oncology Group permanent prostate implant protocol. (Gillin MT, Brachytherapy. 2006 Jul-Sep;5(3):152-6.)
 * PMID 15989995 (2005) -- Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05. (Feigenberg SJ, Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):956-64.)
 * ASCO Poster (2005) -- Correlating prostate seed implant quality with clinical outcomes for patients treated on RTOG protocol 98-05 (A multi-institutional phase II trial of transrectal ultrasound guided prostate seed implant for localized prostate cancer) (Lawton CA, ASCO 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-90, 2005.)
 * PMID 12648789 (2003) -- Impact of target volume coverage with Radiation Therapy Oncology Group (RTOG) 98-05 guidelines for transrectal ultrasound guided permanent Iodine-125 prostate implants (Horwitz EM, Radiother Oncol, 2003). Conclusion : Implementation of the RTOG 98-05 implant planning guidelines has increased coverage of the prostate by the prescription isodose lines compared with our previous technique, as indicated by post-implant dosimetry indices such as V(100), V(90), D(90). The CI was also improved significantly with the protocol guidelines. Our data confirms the validity of the RTOG 98-05 implant guidelines for pre-implant planning as it relates to enlargement of the CTV to ensure adequate margin between the CTV and the prescription isodose lines.
 * ASTRO Abstract (2002) -- Health-Related Quality of Life (HRQOL) in Men Treated with Prostate Brachytherapy Alone on Radiation Therapy Oncology Group (RTOG) Trial 98-05. (Lee WR, ASTRO Abstract 2002, Int J Radiat Oncol Biol Phys [54] (2):47-48, 2002.). Conclusion: The rate of incontinence is low one year following PB but many men have persistent urinary symptoms. Of those men potent at baseline, roughly 80% maintain the ability to have an erection one year following PB although 80% of men also report a decline in sexual function according to the SAQ. At one year more men reported a decline in PWB, PCS and SFWB subscales but more men reported an improvement in the EWB, FWB and RWD subscales.