Radiotherapy and Androgen Deprivation in Combination After Local Surgery. A randomised controlled trial for patients with prostate cancer.
- Conditions
- Prostate CancerMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-000205-34-DK
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 4000
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:
- Patient is due to receive post-operative radiotherapy (adjuvant or salvage).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1802
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2164
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;
- More than 3 months since radical prostatectomy.
Additional Hormone Therapy Duration Randomisation exclusion criteria:
- PSA >10ng/ml at the time of randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To test whether adjuvant treatment with radiotherapy following radical postatectomy leads to better outcomes than regular observation with early salvage treatment given at the tune of a rising PSA - Radiotherapy Timing Randomisation.<br><br>2. To test whether, in men receiving post-operative radiotherapy to the prostate bed, the addition of hormone therapy leads to better outcomes; and if so, whether two years of hormone therapy is better than six months - Hormone Therapy Duration Randomisation;Secondary Objective: Not applicable;Primary end point(s): RADICALS-RT: Freedom from distant metastases<br>RADICALS-HD: Metastasis free survival;Timepoint(s) of evaluation of this end point: September 2022
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Disease-specific survival (i.e. death due to prostate cancer)<br>Freedom from distant metastases<br>Freedom from treatment failure<br>Clinical progression-free survival<br>Overall survival<br>Non-protocol hormone therapy<br>Treatment toxicity<br>Patient reported outcomes<br>Freedom from biochemical progression (RADICALS-RT only);Timepoint(s) of evaluation of this end point: September 2022