Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Study Overview
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Brief Summary
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Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Detailed Description
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Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.

Official Title
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A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically determined adenocarcinoma is required. All other histologies are excluded. Tissue for diagnosis must be obtained by transrectal ultrasound biopsy. Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7. 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0. N0 stage may be assigned following either negative imaging or negative pathologic assessment. Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5. PSA must be less than 20 ng/ml. , Age ≥ 18, IPSS voiding symptoms score must be less than 18, Study consent form must be signed by the patient. Exclusion Criteria: Gleason score of 8 - 10, Clinical stage T3 - T4, Age ≤ 18, Any evidence of nodal (N1) or distant (M1) disease, Prostate volume as assessed by TRUS > 60 cc, PSA > 20 ng/ml, IPSS voiding symptoms score > 18, Prior TURP, Prior pelvic radiotherapy or chemotherapy, Prior prostatectomy, Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years, Current medical or psychiatric illness that may interfere with treatment completion and followup, Hip prosthesis, Unable or unwilling to give informed consent

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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Accepts Healthy Volunteers

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SBRT only<br>Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy | Radiation: SBRT<br>* 8.0 Gy per fraction for 5 fractions for a total of 40 Gy<br>* Other names: SBRT only;|
| Active Comparator: IMRT plus SBRT Boost<br>Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy | Radiation: SBRT<br>* 8.0 Gy per fraction for 5 fractions for a total of 40 Gy<br>* Other names: SBRT only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy | At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years. | Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally confined