Clinical trial · Interventional
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
Postoperative or Salvage Radiotherapy for Node Negative Prostate Cancer Following Radical Prostatectomy
NCT00969111CI-TRIAL-00115156recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE | Radiation | — | UNRESOLVED |
| IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE | Radiation | — | UNRESOLVED |
| Proton (prostate bed) to 70.2 CGE | Radiation | — | UNRESOLVED |
| Proton to 66.6 CGE | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Postop Non-High Risk
- description
- Proton to 66.6 CGE
- interventionNames
- Radiation: Proton to 66.6 CGE
- type
- EXPERIMENTAL
- label
- Postop High Risk
- description
- IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
- interventionNames
- Radiation: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
- type
- EXPERIMENTAL
- label
- Salvage Non-High Risk
- description
- Proton to 70.2 CGE
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * Maximum PSA value of 20 ng/ml. Exclusion Criteria: * 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.
References
Publications (42)
- BACKGROUNDAmerican Cancer Society. 2007. Ref Type: Electronic Citation
- BACKGROUNDThompson 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
- BACKGROUNDBott 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
- BACKGROUNDThompson 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
- BACKGROUNDBolla 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/S0140-6736(05)67101-2. PMID 16099293
- BACKGROUNDBianco 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
- BACKGROUNDStephenson 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: 10.1200/JCO.2006.08.9607.