Efficacy and safety of Decapeptyl® SR by subcutaneous injection in patients with a diagnosis of prostate cancer
- Conditions
- Topic: Renal and Urogenital, National Cancer Research NetworkSubtopic: Renal and Urogenital (all Subtopics)Disease: UrogenitalCancerProstate Cancer
- Registration Number
- ISRCTN02365168
- Lead Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 50
Patients must fulfil all of the following criteria in order to be included in the study:
1. The patient has given written (personally signed and dated) informed consent before starting any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care
2. The patient is male and is 18 years of age or older
3. The patient has a histologically or cytologically confirmed diagnosis of prostate cancer and meets the following criteria:
3.1. Stage T3 or T4, N (any), M (any) with a prostate specific antigen (PSA) greater than 5 ng/ml, or
3.2. Biochemical relapse following radical prostatectomy or radical radiotherapy for prostate cancer
4. Medical castration by means of luteinising hormone releasing hormone agonist (LHRHa) therapy is indicated for the patient
5. The patient has a life expectancy of at least 12 months
6. The patient is able and willing to comply with the requirements of the protocol
Patients who fulfil any of the following criteria, will not be included in the study:
1. The patient has undergone bilateral orchidectomy
2. The patient is either scheduled to receive, receiving, or is anticipated to require any chemotherapy for prostate cancer, or any other cancer, during the period of his participation in the study
3. The patient is either scheduled to receive, or anticipated to require any surgical intervention for their prostate cancer during the period of his study participation
4. The patient has any condition that in the opinion of the Investigator may preclude the administration of subcutaneous Decapeptyl® SR injections
5. The patient has received treatment with any LHRHa within 1 year prior to study entry
6. The patient has a history of hypersensitivity to Decapeptyl® SR or CPA or to any of the excipients of Decapeptyl® SR or CPA
7. The patient has any contraindication to treatment with anti-androgens, including, but not limited to clinically significant abnormalities in liver function
8. The patient has been treated with oestrogens or steroid androgens within the 12 months prior to screening, or is receiving treatment with non-steroid anti-androgens at the time of the screening visit
9. The patient, in the opinion of the Investigator is at risk of serious complications in the event of tumour flare (e.g., vertebral metastases threatening spinal cord compression, significant obstructive uropathy) on initiation of Decapeptyl® SR treatment, despite concomitant treatment with anti-androgens
10. The patient has any other condition that, in the opinion of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
11. The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol
12. The patient has received any investigational drug, within 30 days prior to the study or is scheduled to receive such a drug during the study
13. The patient has a history of, or known current, problems with alcohol abuse
14. The patient has any mental condition rendering him unable to understand the nature, scope and possible consequences of the study
15. The patient has previously been enrolled in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with serum testosterone levels of greater than or equal to 50 ng/dL 4 months after their first injection
- Secondary Outcome Measures
Name Time Method The proportion of patients with serum testosterone levels of greater than or equal to 50 ng/dL 1 month after their first injection