Study Stopped
This study has been terminated due to poor accrual
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
1 other identifier
interventional
6
1 country
11
Brief Summary
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Jul 2007
Typical duration for phase_2 prostate-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
June 11, 2014
CompletedJune 11, 2014
May 1, 2014
3.3 years
August 9, 2007
May 12, 2014
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Up to 5 years
Secondary Outcomes (1)
To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
every 8 weeks
Study Arms (2)
A
EXPERIMENTALTwenty subjects will receive testosterone gel
B
PLACEBO COMPARATORTwenty subjects will receive the placebo
Interventions
Eligibility Criteria
You may qualify if:
- Prostate cancer
- Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
- Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
- Patient must have had a previous trial of anti-androgen therapy
- Patient must have a rising PSA
- No evidence of distant metastatic disease
- ECOG performance status \< 2
- Age \>18 years
- Patients must have normal hepatic function
You may not qualify if:
- Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
- Patients may not be receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients receiving renal dialysis
- Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
- Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Solvay Pharmaceuticalscollaborator
Study Sites (11)
University of Southern California
Los Angeles, California, 90033, United States
University of Colorado
Aurora, Colorado, 80045, United States
Northwestern University
Chicago, Illinois, 60610, United States
University of Chicago
Chicago, Illinois, 60637, United States
NorthShore University Helath System
Evnaston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois Cancer Care
Peoria, Illinois, 61656, United States
University of Maryland
Baltimore, Maryland, 21202, United States
University of Rochester
Rochester, Maryland, 14642, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Geynisman DM, Szmulewitz RZ, Stadler WM. A trial postmortem: challenges in conducting a randomized, double-blind, phase 2 study in men with castration-resistant prostate cancer. Eur Urol. 2012 Nov;62(5):864-6. doi: 10.1016/j.eururo.2012.08.030. Epub 2012 Aug 25. No abstract available.
PMID: 22939385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Walter Stadler
- Organization
- The University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Stadler, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 13, 2007
Study Start
July 1, 2007
Primary Completion
November 1, 2010
Study Completion
August 1, 2012
Last Updated
June 11, 2014
Results First Posted
June 11, 2014
Record last verified: 2014-05