Condition category
Cancer
Date applied
01/12/2010
Date assigned
07/02/2011
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Amit Bahl

ORCID ID

Contact details

Urology Research
Department of Urology
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ON/2008/2781

Study information

Scientific title

A randomised controlled trial to determine the effect of Decapeptyl® on reduction of prostate volume pre-radiotherapy compared with standard therapy (Zoladex®)

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

The Oxfordshire Research Ethics Committee (REC) C, 16/09/2010, ref: 10/H0606/43

Study design

Single-centre single-blind randomised active-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Triptorelin (Decapeptyl®), goserelin (Zoladex®)

Primary outcome measures

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 trial start date

03/01/2011

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

72

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

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research and Innovation Department
University Hospitals Bristol NHS Foundation Trust
Level 3 Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Industry

Funder name

Ipsen Pharma (UK) - Research grant (ref: Y-97-52014-167)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes