Prostate cancer patients who are due to undergo radical radiotherapy to the prostate Cancer Malignant neoplasm of prostate
Conditions
Interventions
Triptorelin (Decapeptyl®) 3 mg or goserelin (Zoladex®) 3.6 mg will be given for three months before radical radiotherapy. All patients will receive a 28 day course of Bicalutamide 50 mg once daily to
however the doctor performing the rectal ultrasound measurements will be blinded to study treatment.
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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. Eastern Cooperative Oncology Group (ECOG) score 0 - 2
Exclusion criteria
Exclusion criteria: 1. Men with stage T4 prostate cancer 2. The patient has any contraindication to treatment with anti-androgens or luteinising hormone-releasing hormone agonist (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 greater than 2 9. Previous transurethral resection of the prostate (TURP) 10. Current indwelling urethral catheter (Patients performing intermittent self catheterisation are not excluded) 11. Prostate volume greater than 100 cc 12. Use of 5-alpha reductase inhibitors (Dutasteride, Finasteride) for less than 6 months 13. Patient is taking medication that is prohibited by the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in size of prostate as measured by trans rectal ultrasound | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who reach serum testosterone castrate levels after the administration of Zoladex® and Decapeptyl® 2. Quality of life using questionnaires EQ5D, QLQ-C30 and QLQ-PR25 | — |
Countries
United Kingdom
Outcome results
None listed