RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

November 8, 2023 updated by: Cheryl Pugh, University College, London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

4236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Cancer Centre
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Health Research Institute
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United Kingdom
    • England
      • Ashford, England, United Kingdom, TN24 0LZ
        • William Harvey Hospital
      • Barnstaple, England, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Basingstoke, England, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Birmingham, England, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Bristol, England, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Canterbury, England, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Crewe, England, United Kingdom, CW1 4QJ
        • Mid Cheshire Hospitals Trust- Leighton Hopsital
      • Croydon, England, United Kingdom
        • Mayday University Hospital
      • Doncaster, England, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Dorchester, England, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Harlow, England, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London
      • London, England, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, England, United Kingdom, N18 1QX
        • Helen Rollason Cancer Care Centre at North Middlesex Hospital
      • London, England, United Kingdom, NW1 2BU
        • University College Hospital
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Manchester, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Romford, England, United Kingdom, RM7 0AG
        • Queen's Hospital
      • Rotherham, England, United Kingdom, S60 2UD
        • Rotherham General Hospital
      • Salford, England, United Kingdom, M6 8HD
        • Hope Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stockport, England, United Kingdom, SK2 7JE
        • Stepping Hill Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden - Surrey
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Uxbridge, England, United Kingdom, UB8 3NN
        • Hillingdon Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Ayr, Scotland, United Kingdom, KA6 6DX
        • Ayr Hospital
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Wakefield, Scotland, United Kingdom, WF1 4DG
        • Pinderfields General Hospital
    • Wales
      • Bodelwyddan, Wales, United Kingdom, LL 18 5UJ
        • Glan Clwyd Hospital
      • Cardiff, Wales, United Kingdom, CF14 2TL
        • Velindre Cancer Center at Velindre Hospital
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Newport, Wales, United Kingdom, NP9 2UB
        • Royal Gwent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RADICALS-RT: Early RT
Radiation: radiation therapy
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Experimental: RADICALS-RT: Salvage RT
Radiation: radiation therapy
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Experimental: RADICALS-HD: Radiotherapy Alone
Radiation: radiation therapy
Procedure: adjuvant therapy
Experimental: RADICALS-HD: Radiotherapy + 6 months
Drug: leuprolide acetate
Drug: goserelin acetate
Radiation: radiation therapy
Procedure: adjuvant therapy
Drug: bicalutamide
Experimental: RADICALS-HD: Radiotherapy + 24 months
Drug: leuprolide acetate
Drug: goserelin acetate
Radiation: radiation therapy
Procedure: adjuvant therapy
Drug: bicalutamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD)
Time Frame: up 12 years
up 12 years
Freedom from distant metastases (any distance metastases or prostate cancer death) (RADICALS-RT)
Time Frame: up 12 years
up 12 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from treatment failure
Time Frame: up 12 years
up 12 years
Clinical progression-free survival
Time Frame: up 12 years
up 12 years
Overall survival
Time Frame: up 12 years
up 12 years
Non-protocol hormone therapy
Time Frame: up 12 years
up 12 years
Treatment toxicity
Time Frame: up 12 years
up 12 years
Patient reported outcomes - EQ5D
Time Frame: up 12 years
up 12 years
Freedom from biochemical progression (RADICALS-RT)
Time Frame: up 12 years
up 12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Canadian Cancer Trials Group

Investigators

  • Study Chair: Christopher Parker, MD, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimated)

October 8, 2007

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000571528
  • MRC-RADICALS-PR10 (Other Identifier: MRC at UCL)
  • ISRCTN40814031 (Registry Identifier: ISRCTN)
  • PR13 (Other Grant/Funding Number: Canadian Cancer Society - Research Institute)
  • 2006-000205-34 (EudraCT Number)
  • NCT00541047 (Other Identifier: NCT)
  • 00316/0223/001-0001 (Other Identifier: CTA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on request via emailing mrcctu.radical@ucl.ac.uk

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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