A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Randomized Phase I Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.

Clinical Trial Description

Most hormone-refractory disease is currently defined by rising PSA following androgen ablation and an antiandrogen. These patients are typically asymptomatic and have minimal or no radiologically evident disease by standard bone and CT scans. Therapeutic options are limited, with 3rd line hormonal treatments generally providing only brief durations of benefit in a small minority of patients. Chemotherapy is effective, but the role of this somewhat toxic approach in the asymptomatic patient is debatable. In addition, patients suffer from the long-term side effects of androgen ablation such as muscle wasting, decreased strength, decreased sexual functioning, and impaired cognition. If the hypothesis that androgen replacement can inhibit cancer growth in androgen insensitive patients is correct, such treatment would not only delay disease progression but could also improve quality of life. If the hypothesis is incorrect and androgens actually stimulate growth, the consequences are unlikely to be catastrophic since the selected population has only a minimal disease burden. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01187485
• Study type: Interventional
• Source: University of Chicago
• Status: Completed
• Phase: Phase 1
• Start date: June 2004
• Completion date: February 2009