Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Phase 2 Completed 34 enrolled Case Comprehensive Cancer Center

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2006-09-01
Primary completion: 2010-08-31
Completion: 2010-08-31

Outcome

Missed primary endpoint

paper The combination of ketoconazole and lenalidomide was well tolerated but did not meet the primary endpoint of response PMID 30191523 ↗

Publications

Barata PC, Cooney M, Mendiratta P, Tyler A, Dreicer R, Garcia JA. Ketoconazole plus Lenalidomide in patients with Castration-Resistant Prostate Cancer (CRPC): results of an open-label phase II study. Invest New Drugs. 2018 Dec;36(6):1085-1092. doi: 10.1007/s10637-018-0660-3. Epub 2018 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Background	Hydrocortisone	Other / unclassified	10 mg	Oral
Background	Hydrocortisone	Other / unclassified	20 mg	Oral