RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\] x 10) is ≤ 15. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
interventionNames
Radiation: 3D-CRT
type
EXPERIMENTAL
label
Group 2
description
Clinical stages T1b-c or T2a-b with PSA + (\[Gleason -6\]x10)\>15. Any clinical T2c with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
interventionNames
Radiation: 3D-CRT
type
EXPERIMENTAL
label
Eligibility
Eligibility (as posted)
Sex
Male
Minimum age
18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Previously untreated adenocarcinoma of the prostate T1b-c or T2a-b with a Gleason score more than 5 and PSA greater than 4 ng/mL OR Any T3 PSA under 70 ng/mL within 3 weeks prior to entry and at least 10 days after prostate biopsy No biopsy proven regional nodal involvement No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Hematopoietic: White blood cell (WBC) count of at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior pelvic irradiation Surgery: No prior prostatectomy or cryosurgery for prostate cancer
References
Publications (21)
BACKGROUNDDu KL, Bae K, Movsas B, Yan Y, Bryan C, Bruner DW. Impact of marital status and race on outcomes of patients enrolled in Radiation Therapy Oncology Group prostate cancer trials. Support Care Cancer. 2012 Jun;20(6):1317-25. doi: 10.1007/s00520-011-1219-4. Epub 2011 Jul 1. PMID 21720747
BACKGROUNDRoach M, Moughan J, Movsas B, et al.: Socio-demographic predictors of biochemical failure and survival among high risk patients treated on Radiation Therapy Oncology Group (RTOG) prostate cancer trials: a meta-analysis. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1127, S204, 2006.
RESULTMichalski J, Winter K, Roach M, Markoe A, Sandler HM, Ryu J, Parliament M, Purdy JA, Valicenti RK, Cox JD. Clinical outcome of patients treated with 3D conformal radiation therapy (3D-CRT) for prostate cancer on RTOG 9406. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):e363-70. doi: 10.1016/j.ijrobp.2011.12.070. PMID 22633552
RESULTTucker SL, Dong L, Michalski JM, Bosch WR, Winter K, Cox JD, Purdy JA, Mohan R. Do intermediate radiation doses contribute to late rectal toxicity? An analysis of data from radiation therapy oncology group protocol 94-06. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):390-5. doi: 10.1016/j.ijrobp.2011.11.073. Epub 2012 Feb 17. PMID 22342302
RESULTTucker SL, Michalski JM, Bosch WR, Mohan R, Dong L, Winter K, Purdy JA, Cox JD. Use of fractional dose-volume histograms to model risk of acute rectal toxicity among patients treated on RTOG 94-06. Radiother Oncol. 2012 Jul;104(1):109-13. doi: 10.1016/j.radonc.2012.04.023. Epub 2012 Jun 5. PMID 22673726
RESULTTucker SL, Thames HD, Michalski JM, Bosch WR, Mohan R, Winter K, Cox JD, Purdy JA, Dong L. Estimation of alpha/beta for late rectal toxicity based on RTOG 94-06. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):600-5. doi: 10.1016/j.ijrobp.2010.11.080. Epub 2011 Mar 4. PMID 21377288
Valicenti RK, Bae K, Michalski J, Sandler H, Shipley W, Lin A, Cox J. Does hormone therapy reduce disease recurrence in prostate cancer patients receiving dose-escalated radiation therapy? An analysis of Radiation Therapy Oncology Group 94-06. Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1323-9. doi: 10.1016/j.ijrobp.2010.01.009.
Group 3
description
Clinical stage T3 with PSA \< 70. Must be lymph node negative. Escalating doses of three dimensional conformal radiation therapy (3D-CRT) until the maximum tolerated dose (MTD) is established.
interventionNames
Radiation: 3D-CRT
Primary outcomes (1)
measure
To establish the maximum tolerated dose (MTD) of radiation that can be delivered to the prostate gland and immediate surrounding tissues in patients with carcinoma of the prostate using three dimensional conformal radiation therapy (3D-CRT).
timeFrame
From registration to approximately 18 months from the start of treatment
Secondary outcomes (3)
measure
To quantify the normal tissue toxicity rate (normal tissue complication probability (NTCP)) for rectum and bladder using 3D-CRT
timeFrame
From registration to approximately 18 months from the start of treatment
measure
To evaluate local control by clinical, pathologic, and PSA (stable in normal range) determinations
timeFrame
From registration to the date of progression or last follow-up. Analysis will occur after the primary endpoint analysis.
measure
Distant metastasis and survival
timeFrame
From registration to the date of death or last follow-up. Analysis will occur after the primary endpoint analysis.
RESULTMichalski JM, Bae K, Roach M, Markoe AM, Sandler HM, Ryu J, Parliament MB, Straube W, Valicenti RK, Cox JD. Long-term toxicity following 3D conformal radiation therapy for prostate cancer from the RTOG 9406 phase I/II dose escalation study. Int J Radiat Oncol Biol Phys. 2010 Jan 1;76(1):14-22. doi: 10.1016/j.ijrobp.2009.01.062. PMID 19577865
RESULTTucker SL, Dong L, Bosch WR, Michalski J, Winter K, Mohan R, Purdy JA, Kuban D, Lee AK, Cheung MR, Thames HD, Cox JD. Late rectal toxicity on RTOG 94-06: analysis using a mixture Lyman model. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1253-60. doi: 10.1016/j.ijrobp.2010.01.069. Epub 2010 Jul 2. PMID 20598811
RESULTCheung MR, Tucker SL, Dong L, et al.: Dose-volume analyses of grade ≥ 2 late rectal toxicity among patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-16, S9, 2007.
RESULTTucker SL, Dong L, Bosch WR, et al.: Fit of a generalized Lyman normal-tissue complication probability (NTCP) model to grade ≥ 2 late rectal toxicity data from patients treated on protocol RTOG 94-06. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-15, S8-9, 2007.
RESULTValicenti RK, Bae K, Michalski J, et al.: Does adjuvant hormonal therapy improve freedom from biochemical relapse in prostate cancer patients receiving dose- escalated radiation therapy? An analysis of RTOG 94-06. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-297, 2007.
RESULTMichalski JM, Winter K, Purdy JA, Parliament M, Wong H, Perez CA, Roach M, Bosch W, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer on RTOG 9406 dose Level V. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):706-13. doi: 10.1016/j.ijrobp.2004.11.028. PMID 15936549
RESULTMichalski JM, Winter K, Purdy JA, Perez CA, Ryu JK, Parliament MB, Valicenti RK, Roach M 3rd, Sandler HM, Markoe AM, Cox JD. Toxicity after three-dimensional radiotherapy for prostate cancer with RTOG 9406 dose level IV. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):735-42. doi: 10.1016/S0360-3016(03)01578-5. PMID 14967428
RESULTRoach M, Winter K, Michalski JM, Cox JD, Purdy JA, Bosch W, Lin X, Shipley WS. Penile bulb dose and impotence after three-dimensional conformal radiotherapy for prostate cancer on RTOG 9406: findings from a prospective, multi-institutional, phase I/II dose-escalation study. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1351-6. doi: 10.1016/j.ijrobp.2004.05.026. PMID 15590164
RESULTMichalski JM, Winter K, Purdy JA, Wilder RB, Perez CA, Roach M, Parliament MB, Pollack A, Markoe AM, Harms W, Sandler HM, Cox JD. Preliminary evaluation of low-grade toxicity with conformal radiation therapy for prostate cancer on RTOG 9406 dose levels I and II. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):192-8. doi: 10.1016/s0360-3016(03)00072-5. PMID 12694838
RESULTMichalski J, Winter K, Purdy JA, et al.: Toxicity following 3D radiation therapy for prostate cancer on RTOG 9406 dose level V. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S151, 2003.
RESULTValicenti RK, Winter K, Cox JD, Sandler HM, Bosch W, Vijayakumar S, Michalski J, Purdy J. RTOG 94-06: is the addition of neoadjuvant hormonal therapy to dose-escalated 3D conformal radiation therapy for prostate cancer associated with treatment toxicity? Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):614-20. doi: 10.1016/s0360-3016(03)00640-0. PMID 14529764
RESULTMichalski JM, Purdy JA, Winter K, Roach M 3rd, Vijayakumar S, Sandler HM, Markoe AM, Ritter MA, Russell KJ, Sailer S, Harms WB, Perez CA, Wilder RB, Hanks GE, Cox JD. Preliminary report of toxicity following 3D radiation therapy for prostate cancer on 3DOG/RTOG 9406. Int J Radiat Oncol Biol Phys. 2000 Jan 15;46(2):391-402. doi: 10.1016/s0360-3016(99)00443-5. PMID 10661346
RESULTRoach M, Winter K, Michalski J, et al.: Mean dose of radiation to the bulb of penis correlates with risk of impotence at 24 months: preliminary analysis of Radiation Therapy Oncology Group (RTOG) phase I/II dose escalation trial 94-06. Int J Radiat Oncol Biol Phys 48(3 suppl): A-2104, 316, 2000.
DERIVEDMcDonald AM, DeMora L, Yang ES, Hoyle JM, Lenzie A, Williams GR, Michalski JM, Yee D, Bahary JP, Den RB, Roach M 3rd, Dess R, Mishra MV, Valicenti RK, Lau HY, Marcrom SR, Souhami L, Mendez LC, Chen Y, Doncals DE, Pugh SL, Feng FY, Sandler HM. Body composition and mortality in men receiving prostate radiotherapy: A pooled analysis of NRG/RTOG 9406 and NRG/RTOG 0126. Cancer. 2023 Mar 1;129(5):685-696. doi: 10.1002/cncr.34596. Epub 2022 Dec 29. PMID 36579470