Single site, phase II, double blind, randomised, placebo controlled study of the effect of dutasteride (Avodart)0.5 mg on the volume and characteristics of prostate cancer, as assessed by multifunctional magnetic resonance imaging (MRI) in a low risk prostate cancer population - MRI in Primary Prostate cancer after Exposure to Dutasteride (MAPPED)
- Conditions
- ow risk prostate cancerMedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2009-012405-18-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion criteria
•Men with low risk prostate cancer: Gleason sum 6 or less, PSA less than 15 ng/ml, T1c to T2a
•Measurable disease on MRI of at least 0.2 cc, based on planimetry volume
•Biopsy proven disease within 2 years of screening visit
•Able to swallow and retain oral medication
•Able and willing to participate in the study for its duration
•Able to read and write (health outcomes questionnaires are written)
•Able to understand instructions related to study procedures and give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1. Subject has ever been treated for prostate cancer with any of the following:
• Radiotherapy (external beam or brachytherapy)
• Chemotherapy
?Surgery
• Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, DES)
• Oral glucocorticoids
• GnRH analogues (e.g., leuprolide, goserelin)
2. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one.
3. Current and/or previous use of the following medications:
• Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 12 months prior to study entry are excluded.
• Any other investigational 5a-reductase inhibitors within the past 12 months.
• Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
• Drugs with antiandrogenic properties within the past 6 months (e.g., spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents)
NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the CRF.
*The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study
4. Contra indication on gadolinium enhanced MRI:
inability to see tumour focus of >/= 0.2cc on T2 sequences
Previous allergic reaction to gadolinium
Serum creatinine > upper limit normal
Incompatible pacemaker
Metal fragments in eyes
Hip replacements which give artefact with prostate /pelvis views
Any artefact or condition which reduces image quality of MRI (eg inability to keep still).
5. Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of involvement.
6. Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
7. Any unstable serious co-existing medical condition(s) including but not limited to: myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
8. Abnormal liver function test (greater than 2 times the upper limit of normal) for
•alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline
•phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
9. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2, as given by UCLH laboratories, due to the risk of a deterioration in renal function with MRI contrast.
11. History of anoth
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method