Study Summary
This trial will investigate whether adding abiraterone acetate + prednisone to the current standard of care (GnRH) can prolong the time until cancer growth is evident, as well as collecting safety information about this combination therapy.
- Prostate Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Maximum up to Month 30.5
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
001
1 of 1
Experimental Treatment
131 Total Participants · 1 Treatment Group
Primary Treatment: abiraterone acetate in combination with prednisone · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 99 · Male Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Who meets the screening criteria for participation in this research?
"This trial is looking for 131 participants with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) between the ages of 18 and 99. To be eligible, candidates must meet the following criteria: PSA of >= 10 ng/mL obtained at screening or PSADT of ≤ 10 months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0 ng/mL, Serum testosterone of < 50 ng/dL(< 2.0 nM), ECOG performance status less than or equal to 2, Be a male >= 18 years of age, Have adenocarcinoma of the prostate, Currently receiving continuous treatment with Gon" - Anonymous Online Contributor
Are there many research centers testing this medication in Canada?
"45 sites are running this clinical trial, with locations in Huntsville, Orange City, San Diego and 42 other cities. To limit travel requirements, patients should try to enroll at the location nearest them." - Anonymous Online Contributor
Are they still enrolling individuals for this research project?
"As of right now, this study is not looking for any more participants. However, it's important to note that the clinical trial was originally posted on May 4th 2011 and updated as recently as October 25th of this year. Additionally, there are nearly 2000 other trials currently open for enrollment." - Anonymous Online Contributor
Do we have any precedent for abiraterone acetate's efficacy when used in concert with prednisone?
"The 647th completed study of abiraterone acetate in combination with prednisone was at Hulston Cancer Center. Currently,378 trials are recruiting patients with a large concentration being in Huntsville, Alabama." - Anonymous Online Contributor
What are the approved indications for abiraterone acetate in combination with prednisone?
"Abiraterone acetate in combination with prednisone can be used to ameliorate the symptoms of thyroiditis, ulcerative colitis, and malignant neoplasms." - Anonymous Online Contributor
What is the FDA's current stance on abiraterone acetate in correlation to prednisone?
"We have rated the safety of abiraterone acetate in combination with prednisone as a 2. This is based on it being a phase 2 trial, where there is data supporting its safety, but none yet for efficacy." - Anonymous Online Contributor
Are individuals aged 30 or more eligible for this research?
"This particular clinical trial is available to patients aged 18 to 99. There are 142 other trials for minors and 1682 studies for senior citizens." - Anonymous Online Contributor
How many participants are allowed in this clinical trial?
"This particular clinical trial is not currently seeking participants. It was originally posted on May 4th, 2011 and last edited on October 25th, 2022. However, there are 1367 trials for prostate cancer and 378 trials involving abiraterone acetate that are actively enrolling patients." - Anonymous Online Contributor