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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: SBRT

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBRT in 4 fraction; Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT	Other: SBRT; 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, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2013
• Primary Completion (Actual): May 23, 2018
• Study Completion (Actual): May 23, 2018

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 1136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No