Plain English Summary
Background and study aims
Decapeptyl is a drug given to men with prostate cancer. Prostate cancer cells need the male hormone testosterone in order to grow and develop. Treatment with hormone suppression therapy reduces the level of testosterone in the body and by doing this reduces the number and size of prostate cancer cells. Decapeptyl (a trade name for a drug called Triptorelin) is a licensed hormone suppression treatment. It is given by an ‘intramuscular’ (IM) injection, which means an injection into muscle. The purpose of this study was to see if Decapeptyl could be administered by subcutaneous (SC) injection, an injection given into the skin, as well as by injection into muscle. If Decapeptyl could be given by SC injection as well as by IM injection patients would have more choice of injection sites and it would make self-administration of the injections easier.
Who can participate?
Men aged at least 18 and diagnosed with prostate cancer.
What does the study involve?
Men who take part in the study attend the outpatient clinic on 5 occasions over approximately 5 months. Two injections of Decapeptyl are given into the skin on the stomach area. Patients are checked at every visit to see if they had experienced any side effects, and blood tests are taken and checked to see if the levels of Prostate Specific Antigen and Testosterone fell as they would if the drug was given into the muscle. Patients are also asked questions to see if they had any problems such as pain or redness at the injection site.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Bristol Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
December 2007 to December 2010
Who is funding the study?
Ipsen Pharma (UK)
Who is the main contact?
Ms Katrina Hurley
Trial website
Additional identifiers
EudraCT number
2006-006595-38
ClinicalTrials.gov number
Protocol/serial number
4918
Study information
Scientific title
A phase II, open-label, single-arm study to assess the efficacy and safety of Decapeptyl® SR (3 mg and 11.25 mg formulations) when administered by subcutaneous injection
Acronym
DISC
Study hypothesis
This is an open-label, single-arm trial designed to assess the efficacy, safety and tolerability of Decapeptyl® SR when administered by subcutaneous injection. Enrolled patients will be those who have a diagnosis of prostate cancer and for whom medical castration by means of androgen deprivation therapy is indicated. Each patient's participation in the trial will last up 5 months (including the screening period).
During the study, patients will receive one injection of Decapeptyl® SR 3 mg (the 1-month sustained release formulation) and one injection of Decapeptyl® SR 11.25 mg (the 3-month sustained-release formulation). The 3 mg injection will be administered at the study visit 2, on day 0 (baseline) and the 11.25 mg injection will be administered one month later, at visit 3. Patients will have additional follow-up visits at month 2 and month 4 (end of study visit).
Ethics approval
Cornwall and Plymouth Research Ethics Committee (REC) approved on the 31/07/2007 (ref: 07/H0203/129)
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Renal and Urogenital, National Cancer Research Network; Subtopic: Renal and Urogenital (all Subtopics); Disease: Urogenital
Intervention
Decapeptyl® SR (3 mg and 11.25 mg) given subcutaneously.
Total duration of treatment: 4 months
Follow-up length: 5 months
Intervention type
Drug
Phase
Phase II
Drug names
Decapeptyl® SR
Primary outcome measure
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
The proportion of patients with serum testosterone levels of greater than or equal to 50 ng/dL 1 month after their first injection
Overall trial start date
04/12/2007
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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:
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
Planned sample size: 50; UK sample size: 50
Participant exclusion criteria
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
Recruitment start date
04/12/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Royal Infirmary
Department of Urology
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
Research and Development
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Ipsen Pharma (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
02/09/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list