Low risk prostate cancer MedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Clinical trial IMP material will be used.
Product Name: Dutasteride
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Dutasteride
Sponsors
University College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily for six months result in a change in volume of prostate cancer, as assessed by MRI (T2 weighted)? ; Secondary Objective: In men with low risk prostate cancer, who seek to adopt expectant management (active surveillance or deferred radical therapy)does exposure to 0.5mg dutasteride once daily result in: 1. Change in volume of prostate cancer as determined by each of a) gadolinium enhanced b) diffusion weighted MRI after 6 months of dutasteride (Avodart) 0.5mg compared to placebo. 2. Change in volume of prostate cancer as determined by each of a) T2 weighted MRI b) gadolinium enhanced MRI c) diffusion weighted MRI after 3 months of dutasteride (Avodart) 0.5mg compared to placebo. 3. Changes in MR characteristics of prostate cancer (perfusion, cell density) between baseline and six months in men on dutasteride (Avodart) 0.5mg compared to placebo. 4. Change in volume of prostate cancer as assessed by HistoScan transrectal ultrasound between baseline and six months. 5. An association between the measured prostate cancer volumes on MRI with the measured prostate cancer volumes on HistoScan at baseli ;Primary end point(s): The primary outcome measure is percentage change in volume of prostate cancer as assessed by T2 weighted MRI at baseline and six months. | — |
Countries
United Kingdom
Outcome results
None listed