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Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

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ClinicalTrials.gov Identifier: NCT00541047
Recruitment Status : Unknown
Verified October 2017 by Medical Research Council.
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2007
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Canadian Cancer Trials Group
Information provided by (Responsible Party):
Medical Research Council

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 8, 2007
Last Update Posted Date October 13, 2017
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
Disease-specific survival (i.e., death due to prostate cancer)
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
Disease-specific survival (i.e. death due to prostate cancer)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
  • Freedom from treatment failure
  • Clinical progression-free survival
  • Overall survival
  • Non-protocol hormone therapy
  • Treatment toxicity
  • Patient reported outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)
Official Title  ICMJE RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Complications
  • Prostate Cancer
  • Sexual Dysfunction
  • Urinary Complications
Intervention  ICMJE
  • Drug: bicalutamide
  • Drug: goserelin acetate
  • Drug: leuprolide acetate
  • Procedure: adjuvant therapy
  • Procedure: quality-of-life assessment
  • Radiation: radiation therapy
Study Arms  ICMJE
  • Experimental: RADICALS-RT: Early RT
    Interventions:
    • Procedure: adjuvant therapy
    • Procedure: quality-of-life assessment
    • Radiation: radiation therapy
  • Experimental: RADICALS-RT: Salvage RT
    Interventions:
    • Procedure: adjuvant therapy
    • Procedure: quality-of-life assessment
    • Radiation: radiation therapy
  • Experimental: RADICALS-HD: Radiotherapy Alone
    Interventions:
    • Procedure: adjuvant therapy
    • Radiation: radiation therapy
  • Experimental: RADICALS-HD: Radiotherapy + 6 months
    Interventions:
    • Drug: bicalutamide
    • Drug: goserelin acetate
    • Drug: leuprolide acetate
    • Procedure: adjuvant therapy
    • Radiation: radiation therapy
  • Experimental: RADICALS-HD: Radiotherapy + 24 months
    Interventions:
    • Drug: bicalutamide
    • Drug: goserelin acetate
    • Drug: leuprolide acetate
    • Procedure: adjuvant therapy
    • Radiation: radiation therapy
Publications * Parker CC, Clarke NW, Cook AD, Kynaston HG, Petersen PM, Catton C, Cross W, Logue J, Parulekar W, Payne H, Persad R, Pickering H, Saad F, Anderson J, Bahl A, Bottomley D, Brasso K, Chahal R, Cooke PW, Eddy B, Gibbs S, Goh C, Gujral S, Heath C, Henderson A, Jaganathan R, Jakobsen H, James ND, Kanaga Sundaram S, Lees K, Lester J, Lindberg H, Money-Kyrle J, Morris S, O'Sullivan J, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Røder MA, Sayers I, Simms M, Wilson J, Zarkar A, Parmar MKB, Sydes MR. Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial. Lancet. 2020 Oct 31;396(10260):1413-1421. doi: 10.1016/S0140-6736(20)31553-1. Epub 2020 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 12, 2017)
4236
Original Enrollment  ICMJE
 (submitted: October 5, 2007)
6100
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Diagnosis of nonmetastatic adenocarcinoma of the prostate
  • Must have undergone radical prostatectomy
  • Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL
  • No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)

Exclusion criteria:

  • Known distant metastases from prostate cancer
  • PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)

PATIENT CHARACTERISTICS:

  • No other active malignancy likely to interfere with protocol treatment or follow-up

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures
  • 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies

Exclusion criteria:

  • Prior hormone therapy
  • Bilateral orchidectomy
  • Prior pelvic radiotherapy
  • Neoadjuvant treatment
  • Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541047
Other Study ID Numbers  ICMJE CDR0000571528
MRC-RADICALS-PR10
ISRCTN40814031
EUDRACT-2006-000205-34
EU-20767
PR13
PR13 ( Other Grant/Funding Number: Canadian Cancer Society - Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Research Council
Study Sponsor  ICMJE Medical Research Council
Collaborators  ICMJE Canadian Cancer Trials Group
Investigators  ICMJE
Study Chair: Christopher Parker, MD Royal Marsden NHS Foundation Trust
PRS Account Medical Research Council
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP