Enrolled patients will be those who have a diagnosis of prostate cancer and for whom medical castration by means of Luteinising Hormone Releasing Hormone analogue (LHRHa) injection is indicated. MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: Decapeptyl SR 3mg
Product Name: Decapeptyl SR
Pharmaceutical Form: Powder for suspension for injection
Concentration unit: mg milligram(s)
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria 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: Stage T3 or T4, N (any), M (any) with a PSA >5ng/ml or Biochemical relapse following radical prostatectomy or radical radiotherapy for prostate cancer 4. Medical castration by means of 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. 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
Exclusion criteria
Exclusion criteria: 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 cyproterone acetate (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 been treated with any investigational drug or therapy, within the last 30 days prior to study entry. 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 the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Decapeptyl SR when given by SC injection in patients with prostate cancer. This will be determined by evaluating the proportion of patients who achieve Serum Total Testosterone Castration Level (STTCL) 4 months after the first injection. ;Primary end point(s): The proportion of patients with Serum Total Testosterone (STT) =50 ng/dL 4 months after their first injection of Decapeptyl SR ; Secondary Objective: 1.To evaluate the efficacy of an initial treatment with Decapeptyl SR 3 mg when given by SC injection. This will be determined by evaluating the proportion of pts who achieve STTCL 1 month after the first injection. 2. To evaluate the efficacy of a repeat treatment with Decapeptyl SR 11.25 mg SC injection. This will be determined by evaluating the proportion of pts who achieve STTCL 1 month after the second injection. 3. To assess changes in plasma triptorelin levels after administration of Decapeptyl SR by SC route at assessment time-points in comparison to Baseline. 4. To assess changes in the levels of Serum Total Testosterone (STT) and Prostate Specific Antigen (PSA), after administration of Decapeptyl SR via the SC route at all assessment time-points in comparison to Baseline. Safety & Tolerability Objectives: 1. To assess the safety of Decapeptyl SR when administered by SC injection. 2. To assess the tolerability of Decapeptyl SR when administered by SC injection. | — |
Countries
United Kingdom
Outcome results
None listed