Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

Официальное название

Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy

Обзор

The purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.

Вмешательства

• Лучевая терапия IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
  Postop High Risk
• Лучевая терапия Proton (prostate bed) to 70.2 CGE
  Salvage Non-High Risk
• Лучевая терапия IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
  Salvage High Risk
• Лучевая терапия Proton to 66.6 CGE
  Post-Op Non High Risk

Первичные конечные точки

• The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy. [Срок оценки: 6 months after the end of radiation therapy]

Вторичные конечные точки (1)

• Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters [Срок оценки: After radiation: every 6 months for 3 years, then annually for 20 years]

Критерии участия

Критерии включения

• Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy.
• Maximum PSA value of 20 ng/ml.

Критерии исключения

• Evidence of distant metastasis (M1).
• Prior systemic chemotherapy for any reason.
• Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
• Prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years.
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Proton Center of Arkansas — Little Rock
• University of Florida Proton Therapy Institute — Jacksonville
• Northwestern Medicine Chicago Proton Center — Warrenville
• McLaren Proton Therapy Center — Flint
• Mercy David C. Pratt Cancer Center — St Louis
• Inova Schar Cancer Institute — Fairfax

Публикации

• American Cancer Society. 2007. Ref Type: Electronic Citation
• Thompson IM Jr, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathologically advanced prostate cancer: a randomized clinical trial. JAMA. 2006 Nov 15;296(19):2329-35. doi: 10.1001/jama.296.19.2329. PMID 17105795
• Bott SR, Freeman AA, Stenning S, Cohen J, Parkinson MC. Radical prostatectomy: pathology findings in 1001 cases compared with other major series and over time. BJU Int. 2005 Jan;95(1):34-9. doi: 10.1111/j.1464-410X.2005.05245.x. PMID 15638892
• Thompson IM, Tangen CM, Paradelo J, Lucia MS, Miller G, Troyer D, Messing E, Forman J, Chin J, Swanson G, Canby-Hagino E, Crawford ED. Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial. J Urol. 2009 Mar;181(3):956-62. doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23. PMID 19167731
• Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S01 PMID 16099293
• Bianco FJ Jr, Scardino PT, Eastham JA. Radical prostatectomy: long-term cancer control and recovery of sexual and urinary function ("trifecta"). Urology. 2005 Nov;66(5 Suppl):83-94. doi: 10.1016/j.urology.2005.06.116. PMID 16194712
• Stephenson AJ, Scardino PT, Kattan MW, Pisansky TM, Slawin KM, Klein EA, Anscher MS, Michalski JM, Sandler HM, Lin DW, Forman JD, Zelefsky MJ, Kestin LL, Roehrborn CG, Catton CN, DeWeese TL, Liauw SL, Valicenti RK, Kuban DA, Pollack A. Predicting the outcome of salvage radiation therapy for recurrent prostate cancer after radical prostatectomy. J Clin Oncol. 2007 May 20;25(15):2035-41. doi: 10.120 PMID 17513807
• Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301. PMID 15685244

Идентификаторы

NCT: NCT00969111 · GU010-18 · UFPTI 0902-PR06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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