SBRT in 4 Fractions for Prostate Cancer

Istituto Clinico Humanitas

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: SBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03873090

1136

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

SBRT in 4 fraction

Experimental group

Description:

Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT

Treatment:

Other: SBRT