Contact information
Type
Scientific
Primary contact
Dr Rosalind Wright
ORCID ID
Contact details
Academic Urology Unit
Institute of Cancer Research and Royal Marsden Hospital
Downs Road
Sutton
London
SM2 5PT
United Kingdom
+44 (0)20 8661 3425
rosalind.wright@icr.ac.uk
Additional identifiers
EudraCT number
2006-000205-34
ClinicalTrials.gov number
NCT00541047
Protocol/serial number
PR10
Study information
Scientific title
Radiotherapy and Androgen Deprivation In Combination After Local Surgery
Acronym
RADICALS
Study hypothesis
RADICALS will test whether giving radiotherapy routinely, within a few months after surgery, rather than waiting for the Prostate-Specific Antigen (PSA) to rise, will reduce the proportion of men who die from prostate cancer. RADICALS will also test whether men receiving radiotherapy after surgery also benefit from the addition of androgen deprivation.
On 15/02/2011 the anticipated end date was changed from 01/04/2012 to 31/05/2013.
On 15/09/2014 the following changes were made to the trial record:
1. Canada, Denmark and Ireland were added to the countries of recruitment
2. The anticipated end date was changed from 31/05/2013 to 01/06/2015
Ethics approval
Royal Free Hospital and Medical School Research Ethics Committee, 18/04/2007, ref: 07/Q0501/48
Study design
Randomised controlled trial with two separate randomisations
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.radicals-trial.org/information_for_patients/patient_information_sheets.aspx
Condition
Prostate cancer
Intervention
Current interventions as of 15/09/2014:
Radiotherapy timing randomisation:
Arm 1A: adjuvant radiotherapy (RT) to prostate bed
Arm 1B: observation policy with early salvage RT to prostate bed given in the event of biochemical failure
Hormone therapy duration randomisation:
Arm 2A: no hormone therapy with radiotherapy
Arm 2B: short-term hormone therapy (6 months) commencing approximately 2 months prior to radiotherapy
Arm 2C: long-term hormone therapy (24 months) commencing approximately 2 months prior to radiotherapy
Previous interventions:
Radiotherapy timing randomisation:
Arm 1A: adjuvant radiotherapy (RT) to prostate bed
Arm 1B: observation policy with early salvage RT to prostate bed given in the event of biochemical failure
Hormone therapy duration randomisation:
Arm 2A: no hormone therapy with radiotherapy
Arm 2B: short-term hormone therapy (4 months) commencing approximately 2 months prior to radiotherapy
Arm 2C: long-term hormone therapy (24 months) commencing approximately 2 months prior to radiotherapy
The previous sponsor for this trial (up to 15/09/2014) was:
Medical Research Council Clinical Trials Unit (UK)
Ian Viney
MRC Centre London
Stephenson House
158-160 North Gower Street
London
NW1 2DA
United Kingdom
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Disease-specific survival (i.e., death due to prostate cancer)
Secondary outcome measures
1. Freedom from treatment failure
2. Clinical progression-free survival
3. Overall survival
4. Non-protocol androgen deprivation
5. Quality of life
6. Treatment toxicity
Overall trial start date
01/09/2006
Overall trial end date
30/09/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient has undergone radical prostatectomy
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Approximately 4000 (to be confirmed, as this depends on actual recruitment)
Participant exclusion criteria
1. Androgen deprivation prior to radical prostatectomy
2. Bilateral orchidectomy
3. Prior pelvic radiotherapy
4. Other active malignancy likely to interefere with protocol treatment or follow-up
5. Known distant metastases from prostate cancer
Recruitment start date
01/09/2006
Recruitment end date
01/06/2015
Locations
Countries of recruitment
Canada, Denmark, Ireland, United Kingdom
Trial participating centre
Academic Urology Unit
London
SM2 5PT
United Kingdom
Sponsor information
Organisation
Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL) (UK)
Sponsor details
2nd Floor David Phillips Building
Polaris House
North Star Avenue
Swindon
SN2 1FL
United Kingdom
+44 (0)20 7670 4651
rmjwlca@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK), ref: C7829/A6381
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Current publication and dissemination plan as of 22/05/2020:
RADICALS-RT comparison: biochemical progression-free survival (early/secondary outcome) – 2020
RADICALS-RT comparison: freedom from distant metastases (primary outcome) – mid 2022
RADICALS-HD comparison: metastases-free survival (new primary outcome) – mid 2022
IPD sharing statement
Please see the unit Data Sharing Policy (https://www.ctu.mrc.ac.uk/our-research/other-research-policy/data-sharing/) and recent paper (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0604-6) regarding the rationale for a controlled access approach.
Previous publication and dissemination plan:
RADICALS-RT comparison: biochemical progression-free survival (early/secondary outcome) – late 2019
RADICALS-RT comparison: freedom from distant metastases (primary outcome) – mid 2022
RADICALS-HD comparison: metastases-free survival (new primary outcome) – mid 2022
IPD sharing statement
Please see the unit Data Sharing Policy (https://www.ctu.mrc.ac.uk/our-research/other-research-policy/data-sharing/) and recent paper (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0604-6) regarding the rationale for a controlled access approach.
Intention to publish date
30/09/2022
Participant level data
Available on request
Basic results (scientific)
Publication list
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17359901
Publication citations
-
Protocol
Parker C, Clarke N, Logue J, Payne H, Catton C, Kynaston H, Murphy C, Morgan R, Morash C, Parulekar W, Parmar M, Savage C, Stansfeld J, Sydes M, , RADICALS (Radiotherapy and Androgen Deprivation in Combination after Local Surgery)., Clin Oncol (R Coll Radiol), 2007, 19, 3, 167-171, doi: 10.1016/j.clon.2007.01.001.