Docetaxel, Androgen Deprivation and Proton Therapy for High Risk Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: < 15% risk of + LN
* Radiation: > 15% risk of + LN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-risk arm A (HR-A)<br>< 15% risk of + lymph nodes (LN) | Radiation: < 15% risk of + LN<br>* Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months.<br>|
| Experimental: HR-B<br>> 15% risk of + LN | Radiation: > 15% risk of + LN<br>* Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Grade 3 or Higher Treatment-related Toxicity Rate. | Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria. | 6 months after the completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters. |  | After radiation: every 6 months for 3 years, then annually for 20 years | 
| Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes. |  | After radiation: every 6 months for 3 years, then annually for 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Proton Radiation