SBRT in 4 Fractions for Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: SBRT

• Registration Number: NCT03873090
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-12
• Primary Completion: 2018-05-23
• Study Completion: 2018-05-23
• Study First Submitted: 2019-02-14
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Study First Posted: 2019-03-13
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT in 4 fraction	SBRT	Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT

Primary Outcome Measures

Name	Time	Method
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.	up to 5 years	Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
Tumour response to local radiation therapy by assessing freedom from biochemical failure.	up to 5 years	Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).