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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01309672 |
Purpose
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: abiraterone acetate Drug: degarelix Drug: goserelin acetate Drug: leuprolide acetate Procedure: orchiectomy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II |
| Estimated Enrollment: | 38 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.
After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically proven diagnosis of adenocarcinoma of the prostate
Must have at least one of the following:
Patients must be receiving ADT (e.g., gonadotropin-releasing hormone (GNRH) antagonist, with or without antiandrogen) prior to entering this study
Suboptimal response to ADT induction as defined by the following criteria:
Declining PSA (current PSA is less than the PSA prior to starting ADT) that fails to reach 4 ng/mL or below despite continuous ADT
No patients with a history of brain metastases or who currently have treated or untreated brain metastases
PATIENT CHARACTERISTICS:
Patients must have controlled blood pressure defined as systolic blood pressure < 160 mm Hg and diastolic blood pressure < 95 mm Hg
No other prior malignancy is allowed except for any of the following:
No patients with active or symptomatic viral hepatitis or chronic liver disease
No history of NYHA class III or IV heart failure
PRIOR CONCURRENT THERAPY:
At least 2 years since prior neoadjuvant or adjuvant gonadotropin-releasing hormone (GNRH) agonist/antagonist therapy (related to previous surgery or radiation)
At least 4 weeks since prior flutamide (6 weeks for bicalutamide and nilutamide) with no evidence of a falling PSA
Contacts and Locations
Show 143 Study Locations| Principal Investigator: | Thomas W. Flaig, MD | University of Colorado, Denver |
More Information
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01309672 History of Changes |
| Other Study ID Numbers: | CDR0000696565, SWOG-S1014 |
| Study First Received: | March 4, 2011 |
| Last Updated: | February 7, 2012 |
| Health Authority: | Unspecified |
|
adenocarcinoma of the prostate hormone-resistant prostate cancer stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Leuprolide Goserelin |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |