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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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RADICALS (MRC PR10)
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Radiotherapy and Androgen Deprivation In Combination After Local Surgery
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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40814031
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EudraCT
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2006-000205-34
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MREC N° |
07/Q0501/48
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UKCRN ID |
1762
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WHO ID
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Research Summary
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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.
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Prostate
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Phase |
III
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Current Status
| Open |
| Closure Date | 01/11/2013 |
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Sample Size
| 4000 |
| Accrual to Date |
 13% |
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Geographical Scope
| International Multi-Centre |
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Lead Country
| England |
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Open to new sites
| Yes, within and outside lead country |
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Additional Information
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There will be an 18 month feasibility phase attached to the beginning of this study
The trial will require international participation
The trial should be relevant to nearly all UK patients undergoing radical prostatectomy
This is planned to be the largest academic trial in this patient group
If you are a patient or relative this link will take you to a description of this trial in plain English on CancerHelp UK
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Main Inclusion Criteria
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Main:
Patient has prostatic adenocarcinoma
Patient has undergone radical prostatectomy
Written informed consent
Inclusion criteria – RADICALS-RT:
Post-op PSA 0.2ng.ml or lower
Between 4 and 22 weeks after surgery
One or more of:
- pT3/4
- Gleason 7-10
- Pre-op PSA 10ng/ml or more
- Positive margins
Inclusion criteria – RADICALS-HD:
Patient due to receive post-operative radiotherapy
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Main Exclusion Criteria
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Main:
Bilateral orchidectomy
Prior pelvic RT
Other active malignancy likely to interfere with protocol treatment or follow-up
Known distant metastases from prostate cancer
Pre-operative hormone therapy within previous 6 months
Previous pre-operative hormone therapy for longer than 8 months
Any post-operative hormone therapy
Exclusion criteria - RADICALS-RT:
Post-operative biochemical failure
More than 22 weeks since surgery
Exclusion criteria - RADICALS-HD:
PSA greater than 5ng/ml at the time of randomisation
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Chief Investigator(s)
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| Dr Christopher Parker |
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Further details, please contact
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Ms Claire Murphy
Medical Research Council
Cancer Division
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
Tel: 020 7670 4747
cm@ctu.mrc.ac.uk
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Funder(s) |
Cancer Research UK
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Sponsor(s) |
Medical Research Council
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