Clinical trial · Interventional
Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer
A Phase II Study of Proton-Based Radiation Therapy With Elective Pelvic Nodal Irradiation, Concomitant Docetaxel, and Adjuvant Androgen Deprivation for High-Risk Prostate Adenocarcinoma
NCT01040624CI-TRIAL-00070143PR05completedN/AResults postedClinicalTrials.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 based radiation combined with low dose chemotherapy and hormonal therapy, has on patients and their cancer.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| < 15% risk of + LN | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-risk arm A (HR-A)
- description
- \< 15% risk of + lymph nodes (LN)
- interventionNames
- Radiation: < 15% risk of + LN
- type
- EXPERIMENTAL
- label
- HR-B
- description
- \> 15% risk of + LN
- interventionNames
- Radiation: > 15% risk of + LN
Primary outcomes (1)
- measure
- Acute Grade 3 or Higher Treatment-related Toxicity Rate.
- timeFrame
- 6 months after the completion of radiation therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \* Adenocarcinoma of the prostate. Exclusion Criteria: * Previous prostate cancer treatment such as chemotherapy and/or pelvic radiation. * Active inflammatory bowel disease (diverticulitis, Crohn's disease or ulcerative colitis) affecting the rectum. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed.) * History of hip replacement. * Prior intrapelvic surgery. This includes the following: * Transrectal or rectal surgery other than polypectomy or hemorrhoid removal or banding * Transabdominal pelvic surgery * Bladder surgery * Prior myocardial infarction (MI) or congestive heart failure (CHF). * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.
References
Publications (53)
- BACKGROUNDAmerican Joint Committee on Cancer. AJCC Cancer Staging Handbook, 6th ed. New York: Springer Verlag; 2002.
- BACKGROUNDMendenhall NP, Li X, Morris CG, Keole S, Mendenhall WM, Nichols RC, Vargas C, Henderson RH, Early GI and GU toxicity in 3 prospective proton therapy trials for prostate cancer. Presented at the American Society of Therapeutic Radiation Oncologists. Chicago, 2009.
- BACKGROUNDAizer AA, Yu JB, McKeon AM, Decker RH, Colberg JW, Peschel RE. Whole pelvic radiotherapy versus prostate only radiotherapy in the management of locally advanced or aggressive prostate adenocarcinoma. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1344-9. doi: 10.1016/j.ijrobp.2008.12.082. Epub 2009 May 21. PMID 19464821
- BACKGROUNDMichalski 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
- BACKGROUNDZelefsky MJ, Levin EJ, Hunt M, Yamada Y, Shippy AM, Jackson A, Amols HI. Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1124-9. doi: 10.1016/j.ijrobp.2007.11.044. PMID 18313526
- BACKGROUNDViale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available. PMID 33532112
- BACKGROUNDD'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.