RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
Condition: Gastrointestinal Complications; Prostate Cancer; Sexual Dysfunction; Urinary Complications
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause
      the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin,
      leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving
      radiation therapy together with androgen deprivation therapy may kill more prostate cancer
      cells.

      PURPOSE: This randomized phase III trial is studying how well giving radiation therapy
      together with androgen deprivation therapy works in treating patients who have undergone
      surgery for prostate cancer.
    

Detailed description: 
      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.
    

Intervention name(s): bicalutamide; goserelin acetate; leuprolide acetate; adjuvant therapy; quality-of-life assessment; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Leuprolide; Goserelin; Bicalutamide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sexual dysfunction; urinary complications; gastrointestinal complications; adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer