Prostate cancer study of CRT + Upfront ADT vs. PHPC + Salvage ADT

Official Title

A Randomized Phase II Study of the Clinical and Metabolic Effects Of Conventional RT with Upfront ADT vs Escalated Dose Hypofractionated RT With Prompt ADT Salvage in High-Risk Prostate Cancer

Summary:

The proposed study will examine the clinical and metabolic implications of using escalated dose hypofractionated RT with prompt ADT salvage in comparison to upfront ADT with conventional RT.

Primary endpoints:

• Development of hormone refractory prostate cancer.
• Changes in metabolic and body composition parameters.

Secondary endpoints:

• Biochemical failure.
• Overall survival.
• Radiation Toxicity

Trial Description

Patients with high risk prostate cancer will be randomized to receive either conventional therapy (conventional RT + upfront ADT) or the investigational therapy (hypofractionated RT + prompt ADT salvage). Patients will be evaluated for acute radiation treatment related toxicities at each visit throughout the treatment period as well as at 6 weeks following the end of treatment.

Patients will continue to be followed at the Cancer Centre in accordance with standard clinical practice as follows:

• PSA testing conducted every 3 months thereafter for 5 years
• Follow-up visits in the clinic at 6 months following the 6 week post end of treatment visit and every 6 months thereafter until 5 years from the start of treatment.

In addition, metabolic evaluations will be conducted at the University of Waterloo at the end of treatment and at 6 months following the 6 week post end of treatment visit.