SBRT in 4 Fractions for Prostate Cancer

Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer

This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.

Inclusion Criteria:

• Age ≤ 85years.
• WHO performance status ≤ 2.
• PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
• Histologically proven prostate adenocarcinoma
• No pathologic lymph nodes on CT/ MRI scan.
• No distant metastases.
• No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
• No malignant tumours in the previous 5 years.
• IPSS 0-7.
• Combined HT according to risk factors.
• Informed consent.

Exclusion Criteria:

• Prostate size greater than 60cc.
• Previous TURP less than 6 weeks before radiotherapy.
• Previous prostate surgery other than TURP.
• Diabetes *.
• Use of anticoagulants drugs *.
• Chronic inflammatory bowel disease *.
• Previous pelvic irradiation.
• Inability to obtain written informed consent.