NCT03380806

Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Juravinski Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

Detailed description

In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	LHRH agonist	Standard LHRH agonist for 3 years
RADIATION	Pelvic Radiation	Pelvic Radiation
RADIATION	Stereotactic Body Radiotherapy (SBRT)	SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
RADIATION	Conventional Radiotherapy (CRT) Prostate Boost	CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2017-12-21
• Last updated: 2020-06-04

Locations

2 sites across 1 country: Canada