SBRT in 4 Fractions for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873090
• Other study ID #: 1136
• Status: Completed
• Phase: N/A
• Start date: June 12, 2013
• Est. completion date: May 23, 2018

Study information

• Verified date: March 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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 a/ß estimate between 3 and 1.5 Gy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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