Radiation and Androgen Ablation for Prostate Cancer

Study Overview
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Brief Summary
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A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

Detailed Description
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This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.

Official Title
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Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

Conditions
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Adenocarcinoma of the Prostate

Intervention / Treatment
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* Radiation: Radiation Therapy
* Drug: Androgen Deprivation Therapy (ADT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed, locally confined adenocarcinoma of the prostate Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7). The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. Signed study-specific consent form prior to registration Exclusion Criteria: Stage T3-4 disease. Gleason 8 or higher score. PSA > 20 ng/ml. IPSS (International Prostate Symptom Score) > 15 Clinical or Pathological Lymph node involvement (N1). Evidence of distant metastases (M1). Radical surgery for carcinoma of the prostate. Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer. Previous pelvic radiation therapy. Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years. History of inflammatory bowel disease. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11 Liver function tests (LFTs) greater than twice the upper limit of normal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation with Androgen Deprivation Therapy (ADT)<br>This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. | Radiation: Radiation Therapy<br>* 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)<br>Drug: Androgen Deprivation Therapy (ADT)<br>* Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical failure free-rate | To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. | 1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various Control Rate Assessments | Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT. | 1 year | 
| Dose Volume/ Imaging Data Assessments | Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy. | 1 year | 
| Biomarker Studies | Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies. | 1 year | 
| Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment | 1) Assess the incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. | 1 year |