A Randomised Controlled Trial to Determine the Effect of Decapeptyl on Reduction of Prostate Volume Pre-Radiotherapy Compared with Standard Therapy (Zoladex) - Effect of Decapeptyl on Prostate Volume Pre Radiotherapy (EDVART)
- Conditions
- Enrolled patients will be those with a diagnosis of prostate cancer who require radiotherapy to the prostate, with medical castration by means of Luteneising Hormone Releasing Hormone analogue (LRHRa) injections before radiotherapy commences.MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
- Registration Number
- EUCTR2008-007028-25-GB
- Lead Sponsor
- niversity Hospitals Bristol NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
1. Patients with histologically proven prostate cancer
2. Patients who are eligible for and have chosen radical radiotherapy (external beam or brachytherapy) as their treatment
3. The patient has given written (personally signed and dated) informed consent before starting any study-related procedure
4. The patient is male and is 18 years of age or older
5. The patient is able and willing to comply with the requirements of the protocol
6. ECOG score 0 – 2
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Men with stage T4 prostate cancer
2. The patient has any contraindication to treatment with anti-androgens or LHRHa therapy.
3. The patient has received treatment with any LHRHa or anti-androgen therapy within 1 year prior to study entry
4. The patient has been treated with oestrogens or steroid androgens within the 12 months prior to study entry, or is receiving treatment with oestrogens or non-steroid anti-androgens at the time of study entry.
5. The patient has any condition rendering him unable to understand the nature, scope and possible consequences of the study.
6. The patient has received any investigational drug therapy within 30 days prior to study entry, or is scheduled to receive such a drug during the study period.
7. The patient is either scheduled to receive, receiving or anticipated to require any chemotherapy for prostate cancer or any other cancer during the period of his participation in the study
8. ECOG score >2
9. Previous TURP
10. Current indwelling urethral catheter (Patients performing intermittent self catheterisation are not excluded)
11. Prostate volume >100cc
12. Use of 5alpha reductase inhibitors (Dutasteride, Finasteride) for less than 6 months.
13. Patient is taking medication that is prohibited by the study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate the efficacy, in terms of reduction in prostate size, of a three month course of Decapeptyl 3mg as compared to Zoladex 3.6mg when given before treatment with radical radiotherapy to the prostate.;<br> Secondary Objective: 1. Is there any difference in quality of life between the two groups of patients.<br> 2. Do patients in either group reach a lower level of serum testosterone.<br> ;Primary end point(s): Reduction in prostate size as measured by trans-rectal ultrasound
- Secondary Outcome Measures
Name Time Method