Clinical Trial Detail

We are seeking men for two separate parts of this study:

1) Control Group: Survivors of prostate cancer who are 6 months post primary treatment.

2) Treatment Group: Men with prostate cancer who are about to start hormone treatment with androgen deprivation therapy (ADT). Note: For the treatment group, participants must be enrolled in this study BEFORE starting ADT.

This is an outpatient study at the Seattle Cancer Care Alliance (SCCA) or Veterans Affairs Medical Center (VA) in Seattle. Participants will complete approximately 6 visits. Each visit will last about 2-3 hours and will include a blood draw.

Participants in the Treatment Group will receive either a testosterone gel or a placebo gel, to be used for one month following treatment with ADT. (The placebo gel is an inactive substance.) Participants will receive the gel and instructions in how to use it at the SCCA.

- More than 6 months have passed since last treatment for prostate cancer

- Not currently undergoing cancer treatment

2) Treatment Group - Men with prostate cancer who have not yet started treatment with androgen deprivation therapy (ADT):

- Must be eligible for ADT

- Must NOT have started ADT yet

All participants:

- Able to travel to the Seattle Cancer Care Alliance (SCCA) or Veterans Affairs Medical Center (VA) in Seattle

- Committed to completing all visits

- Primary language is English

Other eligibility criteria may apply.

- Evidence of metastatic disease

- History of significant neurological disease such as Parkinson's, multiple sclerosis (MS), epilepsy/seizures, or major stroke

- History of head injury/trauma

- History of alcohol abuse, current alcohol abuse, or other substance abuse

- Major psychiatric illness such as schizophrenia or bipolar disorder

Other exclusion criteria may apply.

2) Treatment Group (Men with prostate cancer who have not yet started treatment with and