Effect of Decapeptyl® on prostate Volume pre-RadioTherapy
| ISRCTN | ISRCTN72793878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72793878 |
| EudraCT/CTIS number | 2008-007028-25 |
| Secondary identifying numbers | ON/2008/2781 |
- Submission date
- 01/12/2010
- Registration date
- 07/02/2011
- Last edited
- 28/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Amit Bahl
Scientific
Scientific
Urology Research
Department of Urology
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
Study information
| Study design | Single-centre single-blind randomised active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial to determine the effect of Decapeptyl® on reduction of prostate volume pre-radiotherapy compared with standard therapy (Zoladex®) |
| Study acronym | EDVART |
| Study hypothesis | The purpose of the study is to determine the cytoreductive efficacy of Decapeptyl® when used before radical radiotherapy (external beam radiotherapy or brachytherapy) to the prostate. Decapeptyl® will be compared in effect to Zoladex®, in order to show whether it gives as good an effect in reducing prostate size before radiotherapy. |
| Ethics approval(s) | The Oxfordshire Research Ethics Committee (REC) C, 16/09/2010, ref: 10/H0606/43 |
| Condition | Prostate cancer patients who are due to undergo radical radiotherapy to the prostate |
| Intervention | 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 prevent tumour flare with the first injection of their LHRHa therapy. Each patients involvement in the study will last for 14 weeks. The study will run for 2 years and we are hoping to start in January, estimated last patient last visit is 31/01/2012. Due to drug formulations a fully blinded study is not possible; however the doctor performing the rectal ultrasound measurements will be blinded to study treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Triptorelin (Decapeptyl®), goserelin (Zoladex®) |
| Primary outcome measure | Reduction in size of prostate as measured by trans rectal ultrasound |
| Secondary outcome measures | 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 |
| Overall study start date | 03/01/2011 |
| Overall study end date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 72 |
| Total final enrolment | 71 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 14/02/2011 |
| Recruitment end date | 31/05/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Innovation Department
University Hospitals Bristol NHS Foundation Trust
Level 3 Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Industry
Ipsen Pharma (UK) - Research grant (ref: Y-97-52014-167)
No information available
Results and Publications
| Intention to publish date | 31/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Abstract results | quality of life results presented at ASCO | 20/02/2017 | 21/02/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/10/2020: Cancer Research UK lay results summary link added to Results (plain English).
21/02/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The EudraCT number has been added.
23/01/2019: Intention to publish date has been added.
11/12/2017: No publications found, verifying study status with principal investigator.
