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

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.

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