Trial Information

RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

OBJECTIVES:

- Assess the timing of radiotherapy and the use of hormone therapy in conjunction with
post-operative radiotherapy.

- Determine the impact of radiotherapy on general quality of life, sexual function,
urinary function, and bowel function.

- Determine the impact of duration of hormone therapy on general quality of life and
sexual function.

OUTLINE: This is a multicenter study. Patients requiring immediate radiotherapy (RT) are
assigned to arm I; patients do not require immediate RT are assigned to arm II. Patients for
whom the need of immediate post-operative radiotherapy are uncertain undergo radiotherapy
timing randomization within 3 months after surgery and are randomized to 1 of 2 radiotherapy
arms.

- Arm I (immediate RT): Within 2 months after randomization, patients undergo
radiotherapy to the prostate bed once a day, 5 days a week, for 4 (20 fractions total)
or 6.5 weeks (33 fractions total). They may also undergo radiotherapy to the pelvic
lymph nodes once a day, 5 days a week, for 4.5 weeks (23 fractions total) at the
investigator's discretion.

- Arm II (early salvage RT in case of PSA failure): Within 2 months of confirmation of
post-operative biochemical failure, patients undergo radiotherapy as in arm I.

Patients undergoing immediate RT and patients who eventually need early salvage RT undergo
hormone therapy duration randomization before the administration of post-operative
radiotherapy. Patients are randomized to 1 of 3 hormone therapy arms.

- Arm III (no hormone therapy): Patients do not receive hormone therapy. They receive
post-operative RT alone as described above in arm I or II.

- Arm IV (RT and short-term hormone therapy): Beginning approximately 2 months prior to
the start of RT, patients receive hormone therapy for 6 months. Hormone therapy* may
comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g.,
goserelin or leuprolide acetate]) or bicalutamide daily.

- Arm V (RT and long-term hormone therapy): Beginning approximately 2 months prior to the
start of RT, patients receive hormone therapy for 24 months. Hormone therapy* may
comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g.,
goserelin or leuprolide acetate]) or bicalutamide daily.

NOTE: *For Canadian patients, hormonal therapy will consist of LHRH analog (leuprolide
acetate) therapy only.

Treatment continues in the absence of disease progression or unacceptable toxicity. Quality
of life is assessed using self-administered questionnaires at baseline and 1, 5, and 10
years after randomization. Health economics information is also collected via
patient-administered questionnaires (EQ-5D) at baseline and at 1, 5 and 10 years after
randomization.

After completion of study treatment, patients are followed for 7 years.