EUCTR2006-000205-34-GB
Active, not recruiting
Phase 1
Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer. - RADICALS
niversity College London0 sites4,000 target enrollmentDecember 10, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- niversity College London
- Enrollment
- 4000
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be joining one or both randomisations.
- •Main inclusion criteria (both randomisations):
- •\- Patient has undergone radical prostatectomy;
- •\- Patient has prostatic adenocarcinoma;
- •\- Patient has given written informed consent.
- •Additional Radiotherapy Timing Randomisation inclusion criteria:
- •\- Post\-operative serum PSA is \< 0\.4ng/ml;
- •\- It is within 3 months after radical prostatectomy;
- •\- There is uncertainty, in the opinion of the clinician and patient, regarding the need for immediate post\-operative radiotherapy.
- •Additional Hormone Therapy Duration Randomisation inclusion criteria:
Exclusion Criteria
- •Main exclusion criteria (both randomisations):
- •\- Prior hormone therapy;
- •\- Prior bilateral orchidectomy;
- •\- Prior pelvic radiotherapy;
- •\- Other active malignancy likely to interfere with protocol treatment or follow\-up;
- •\- Known distant metastases from prostate cancer;
- •\- Neoadjuvant treatment;
- •\- Hypogonadism (testosterone \<50ng/dL).
- •Additional Radiotherapy Timing Randomisation exclusion criteria:
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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