Radiotherapy and Androgen Deprivation In Combination After Local Surgery
| ISRCTN | ISRCTN40814031 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40814031 |
| EudraCT/CTIS number | 2006-000205-34 |
| ClinicalTrials.gov number | NCT00541047 |
| Secondary identifying numbers | PR10 |
- Submission date
- 28/06/2006
- Registration date
- 31/10/2006
- Last edited
- 20/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Academic Urology Unit
Institute of Cancer Research and Royal Marsden Hospital
Downs Road
Sutton
London
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 3425 |
|---|---|
| rosalind.wright@icr.ac.uk |
Study information
| Study design | Randomized controlled trial with two separate randomisations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.radicals-trial.org/information_for_patients/patient_information_sheets.aspx |
| Scientific title | Radiotherapy and Androgen Deprivation In Combination After Local Surgery |
| Study acronym | RADICALS |
| Study objectives | 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. |
| Ethics approval(s) | Royal Free Hospital and Medical School Research Ethics Committee, 18/04/2007, ref: 07/Q0501/48 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2006 |
| Completion date | 28/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target number of participants | Approximately 4000 (to be confirmed, as this depends on actual recruitment) |
| Total final enrolment | 4236 |
| Key inclusion criteria | Patient has undergone radical prostatectomy |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/06/2015 |
Locations
Countries of recruitment
- Canada
- Denmark
- England
- Ireland
- United Kingdom
Study participating centre
SM2 5PT
United Kingdom
Sponsor information
University/education
Institute of Clinical Trials & Methodology
90 High Holborn
2nd Floor
London
WC1V 6LJ
England
United Kingdom
| Phone | +44 (0)20 7670 4651 |
|---|---|
| mrcctu.radicals@ucl.ac.uk | |
| Website | https://www.mrcctu.ucl.ac.uk/ |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/04/2007 | Yes | No | |
| Abstract results | RADICALS-HD | 12/09/2022 | 08/12/2022 | No | No |
| Other publications | 28/09/2020 | 08/12/2022 | Yes | No | |
| Other publications | RADICALS-HD | 06/07/2022 | 08/12/2022 | Yes | No |
| Results article | RADICALS-RT | 31/10/2020 | 08/12/2022 | Yes | No |
| Statistical Analysis Plan | RADICALS-HD and RADICALS-RT | 27/05/2022 | 08/12/2022 | No | No |
| Results article | RADICALS-HD | 16/05/2024 | 20/05/2024 | Yes | No |
| Results article | RADICALS-HD | 16/05/2024 | 20/05/2024 | Yes | No |
Editorial Notes
20/05/2024: Publication references added.
08/12/2022: The following changes were made to the trial record:
1. Publication references and total final enrolment added
2. Sponsor details updated.
3. The overall trial end date was changed from 30/09/2022 to 28/07/2022.
22/05/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/06/2015 to 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.
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
15/02/2011: The anticipated end date was changed from 01/04/2012 to 31/05/2013.
