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Abiraterone Post Ketoconazole for Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Abiraterone Post Ketoconazole for Prostate Cancer

A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole

NCT01199146•University of California, San Francisco

View on ClinicalTrials.gov

Summary

This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole. It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the prostate
•Prior therapy with ketoconazole for castration resistant prostate cancer. Patients should demonstrate evidence of progression (see below definitions) on ketoconazole or evidence of grades 3/4 toxicities on ketoconazole.
•1. Ketoconazole must have been administered for \>28 days
•2. At least 27 days must elapse since last ketoconazole dose and first dose of abiraterone acetate
•No prior therapy with chemotherapy for metastatic prostate cancer
•Metastatic disease based on a positive bone scan or objective imaging on CT scan
•Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
•Testosterone \< 50 ng/dL
•Progressive disease after androgen deprivation: PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2 successive occasions, at least 2 weeks apart
•Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen
+7 more criteria

Exclusion Criteria

•Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks prior to first dose of study drug
•Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following; conventional multivitamin supplements, Selenium, Lycopene and Soy supplements
•Prior radiation therapy completed \< 4 weeks prior to enrollment
•Prior chemotherapy for castration resistant prostate cancer. Patients who have received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant or adjuvant trial) or for other malignancies are eligible provided that \>1 year has passed since the administration of the last chemotherapy dose.
•Hemoglobin ≤9.0 g/dL
•Any "currently active" second malignancy, other than non-melanoma skin cancer Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
•Blood pressure that is not controlled despite \>2 oral agents (SBP \>160 and DBP \>90 on three or more readings within the screening period)
•Serum K+ \<3.5 mmoL/L on more than one reading within the screening period
•NYHA Class II, NYHA Class III or IV Congestive Heart Failure
•Myocardial infarction within the 6 months prior to the first dose of study drug
+2 more criteria

Locations (2)

University of California, San Francisco

San Francisco, California, United States

University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

September 10, 2010

Primary Completion Date

January 4, 2013

Completion Date

March 14, 2016

Last Updated

January 8, 2018

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Abiraterone acetate

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Abiraterone Post Ketoconazole for Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC