Testosterone in Metastatic Renal Cell Carcinoma Patients

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: Male

Summary

Purpose

To determine efficacy and safety of Testosterone in male patients with metastatic renal cell carcinoma and fatigue receiving targeted therapy or checkpoint inhibitors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kidney Cancer Research Bureau
• Treatments: Methyltestosterone; Sunitinib; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Histologically proven clear cell renal cell carcinoma;

2. CT-confirmed metastatic measurable disease;

3. First-line sunitinib or pazopanib treatment with fatigue;

4. Low level of testosterone;

4. Male, 18 years and older; 5. Normal PSA level

Exclusion Criteria:

1. Prostate and other cancers history

2. Hypothyroidism

3. History of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)