Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002760
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
1999-11-01
Brief Title:
Antiandrogen Withdrawal in Treating Patients With Hormone-Refractory Prostate Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A PHASE III TWO-ARM RANDOMIZED STUDY COMPARING ANTIANDROGEN WITHDRAWAL ALONE VERSUS ANTIANDROGEN WITHDRAWAL COMBINED WITH KETOCONAZOLE AND HYDROCORTISON IN PATIENTS WITH ADVANCED PROSTAGE CANCER
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antiandrogen withdrawal may be an effective treatment for prostate cancer
PURPOSE Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy
PURPOSE Randomized phase III trial to study the effectiveness of ketoconazole and hydrocortisone for antiandrogen withdrawal in treating men with prostate cancer that is refractory to hormone therapy
Detailed Description:
OBJECTIVES I Compare the response rate and duration of response to antiandrogen withdrawal alone vs antiandrogen withdrawal plus ketoconazolehydrocortisone in patients with advanced hormone-refractory prostate cancer II Compare the response rate and duration of response to ketoconazolehydrocortisone in patients treated with previous vs simultaneous antiandrogen withdrawal III Evaluate the proportion of patients with circulating prostate cancer cells identified by reverse transcriptase-polymerase chain reaction rt-PCR IV Determine whether rt-PCR positively correlates with response V Compare the likelihood of response to these regimens in patients whose prior hormonal therapy consisted of initial combined androgen blockage vs initial monotherapy followed later by an antiandrogen VI Correlate adrenal androgen synthesis suppression as measured by levels of various adrenal androgens with response
OUTLINE Randomized study Patients who develop progressive disease on Arm I cross to Arm II Arm I Antiandrogen Withdrawal Antiandrogen stopped Arm II Antiandrogen Withdrawal plus Adrenal Androgen Blockade Antiandrogen stopped plus Ketoconazole KCZ Hydrocortisone HC NSC-10483
PROJECTED ACCRUAL Approximately 250 patients will be entered over 3 years to attain 238 eligible patients including 25-40 minority patients
OUTLINE Randomized study Patients who develop progressive disease on Arm I cross to Arm II Arm I Antiandrogen Withdrawal Antiandrogen stopped Arm II Antiandrogen Withdrawal plus Adrenal Androgen Blockade Antiandrogen stopped plus Ketoconazole KCZ Hydrocortisone HC NSC-10483
PROJECTED ACCRUAL Approximately 250 patients will be entered over 3 years to attain 238 eligible patients including 25-40 minority patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064708 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9583 | None | None | None |