Dutasteride in Treating Patients With Prostate Cancer

NCT01193855 | Unknown Phase 2

• 4 other identifiers: CDR0000684018UCL-09-0221EUDRACT-2009-012405-18EU-21067
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well giving dutasteride works in treating patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• The change in volume of foci of prostate cancer (PC) as assessed by T2-weighted (T2w) MRI between baseline and 6 months

Secondary Outcomes (8)

• The change in volume of PC as determined by gadolinium-enhanced (GE) MRI and diffusion-weighted (DW) MRI at 6 months

• The change in volume of PC as determined by T2w MRI, GE MRI, and DW MRI at 3 months

• The changes in MR characteristics of PC (perfusion, cell density) between baseline and 6 months

• The change in volume of PC as assessed by HistoScan transrectal ultrasound (TRUS) between baseline and 6 months

• The association between the measured PC volumes on MRI with the measured PC volumes on TRUS at baseline and 6 months

Interventions

dutasteride DRUG

gadolinium-chelate DRUG

active surveillance OTHER

diffusion-weighted magnetic resonance imaging PROCEDURE

functional magnetic resonance imaging PROCEDURE

prostate biopsy PROCEDURE

ultrasound imaging PROCEDURE

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer, meeting all of the following criteria: * Prostate-specific antigen (PSA) \< 10.0 ng/mL * T1c-T2a disease * Gleason sum of 6 or 7 (secondary pattern 4 only) * Patients with low risk disease must meet the following criteria: * Gleason pattern 3 + 3 * PSA \< 10.0 ng/mL * Clinical T2a disease * Patients with Gleason secondary pattern 4 (i.e., Gleason Pattern 3 + 4) are eligible but must not have a primary pattern 4, PSA \> 10 ng/mL, or clinical T2b disease * Measurable disease on MRI of at least 0.2 cc, based on planimetry volume * Biopsy-proven disease within 2 years of screening visit * No biopsy artifact on MRI scan (minimum 12-week interval between biopsy and baseline MRI) * Eligible for active surveillance according to the criteria set out by the National Institute for Health and Clinical Excellence PATIENT CHARACTERISTICS: * ALT and AST ≤ 2 times the upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * Bilirubin ≤ 1.5 times ULN * Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min * 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 * No history of another malignancy within five years that could affect the diagnosis of prostate cancer * No history or current evidence of drug or alcohol abuse within the last 12 months that might confound the results of the study or pose additional risk to the patient * No known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride * No contraindication for undergoing gadolinium-enhanced MRI, including any of the following: * Inability to see tumor focus of ≥ 0.2 cc on T2 sequences * Previous allergic reaction to gadolinium * Serum creatinine \> ULN * Incompatible pacemaker * Metal fragments in eyes * Hip replacements that give artifact with prostate/pelvis views * Any artifact or condition that reduces image quality of MRI (e.g., inability to keep still) * No unstable serious co-existing medical condition(s) including, but not limited, to any of the following: * 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 * Peptic ulcer disease uncontrolled by medical management PRIOR CONCURRENT THERAPY: * No prior radiotherapy (external-beam or brachytherapy), high-intensity focused ultrasound (HIFU), or photodynamic therapy (PDT) * No prior chemotherapy * At least 3 months since prior and no concurrent prostatic surgery, including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation * No prior oral glucocorticoids * Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one * No prior GnRH analogues (e.g., leuprolide, goserelin) * No prior or concurrent hormonal treatment (e.g., megestrol, medroxyprogesterone, cyproterone, DES) of prostate cancer * No current and/or prior use of the following medications: * Finasteride (Proscar, Propecia), or dutasteride (GI198745, AVODART) exposure within 12 months prior to study entry * Any other investigational 5α-reductase inhibitors within the past 12 months * Anabolic steroids within the past 6 months * Drugs with antiandrogenic properties within the past 6 months (e.g., spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) * The use of cimetidine is permitted prior to study entry * The use of topical ketoconazole is permitted prior to and during the study * No participation in another investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College London Hospitals: lead

Study Sites (1)

University College of London Hospitals

London, England, W1T 7NF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride; Watchful Waiting; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mark Emberton, MD, FRCS, MBBS

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2011-08

Locations

GB (1)