Condition category
Cancer
Date applied
28/06/2006
Date assigned
31/10/2006
Last edited
22/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.ctu.mrc.ac.uk

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

  1. 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.

Additional files

Editorial Notes

22/05/2020: The following changes have been made: 1. The overall trial end date has been changed from 01/06/2015to 30/09/2022. 2. The intention to publish date has been changed from 31/12/2019 to 30/09/2022. 3. The publication and dissemination plan has been updated. 01/07/2019: Publication and dissemination plan and IPD sharing statement added. 14/06/2019: No publications found. Verifying results with principal investigator. 18/10/2018: No publications found, verifying study status with principal investigator.