Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Methyltestosterone

Hormones

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Study subjects will be randomized to one of the study arms: 2.5 mg of Androderm®.

Study subjects will be randomized to one of the study arms: 5.0 mg of Androderm®.

Study subjects will be randomized to one of the study arms: 7.5 mg of Androderm®.

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

Androderm® 2.5mg

Androderm® 5.0mg

Androderm® 7.5mg

Walter M Stadler, MD

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.

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.

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

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

To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.

To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA. To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on QOL, sexual functioning, and muscle strength.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer	NCT01187485	Prostate Cancer	Androderm® 2.5m... Androderm® 5.0m... Androderm® 7.5m...	18 Years -	University of Chicago
A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer	NCT01187485	Prostate Cancer	Androderm® 2.5m... Androderm® 5.0m... Androderm® 7.5m...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for androderm® 2.5mg