At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the prostate
- ✓Testosterone suppressed to less than 50 ng/dL
- ✓Progressive disease documented after androgen deprivation
- ✓Age 18 years or older
- ✕Prior systemic chemotherapy for hormone refractory prostate cancer (unless completed ≥12 months ago as neoadjuvant/adjuvant)
- ✕Prior ketoconazole, aminoglutethimide, or corticosteroids for treatment of progressive prostate cancer
- ✕Prior immunotherapy including vaccines, thalidomide, or lenalidomide-like agents
- ✕Any prior use of lenalidomide
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation
In Brief
A Phase 2 clinical trial evaluating ketoconazole, lenalidomide, and 1 other intervention for Prostate Cancer. Completed, enrolled 34 participants across 6 sites.
Detailed Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone together with lenalidomide works in treating patients with prostate cancer that did not respond to hormone therapy.
Study Details
Timeline
Interventions
400 tid
Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
20mg qam 10mg qhs