Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02415621|
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : February 6, 2018
Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA) to treat metastatic prostate cancer at 1000 mg daily.
The purpose of this study is to find out if an on and off schedule of taking abiraterone would prolong the participant's cancer's response to this drug and maintain their functionality to perform their daily activities.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Abiraterone Acetate||Not Applicable|
In this pilot study, 10 black participants and 15 non-black participants will be enrolled after achieving 50% or more decline of their prostatic specific antigen (PSA) while on abiraterone for asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). Abiraterone will be stopped and will not be re-initiated until there is 50% or more increase of the PSA. Each time abiraterone is stopped, it will be defined as the start of a new adaptive therapy cycle. Participants who cannot achieve a 50% decline of their PSA after restarting abiraterone will continue abiraterone until they develop radiographic disease progression. If the decline in performance status does not occur at the time of radiographic disease progression, participants will be followed until they develop radiographic disease progression.
The study will be terminated early if less than 3 of the first 10 enrolled participants can complete 2 cycles of the adaptive abiraterone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer|
|Actual Study Start Date :||April 8, 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Abiraterone Acetate Therapy
Study schedule involves stopping FDA Approved abiraterone after participants achieve a good PSA response (50% or more decline of pre-abiraterone PSA) and then restarting abiraterone after their PSA reaches the level of pre-abiraterone PSA.
Drug: Abiraterone Acetate
1000 mg by mouth (PO) every day (QD)
Other Name: Zytiga
- Prostatic Specific Antigen (PSA) Response Rate [ Time Frame: End of cycle 2: 2 months per participant ]PSA response rate (defined as 50% decline of pre abiraterone PSA) at cycle 2. Rate in black participants, non-black participants, and participants overall.
- Median Radiographic Progression-Free Survival (rPFS) [ Time Frame: Up to 36 months ]Radiographic progression defined by any of the following: 1.) Progression of measureable lesions per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over pretreatment baseline if no decrease during therapy) using the same imaging techniques as baseline, as well as an absolute increase of at least 0.5 cm. 2.) Progression on bone scan is defined as 2 or more new lesions on radionuclide bone scans. 3.) Unequivocal progression evidenced by appearance of 2 or more new measurable lesions at least 2 cm in short axis. Rate in black participants, non-black participants, and participants overall.
- Median Time to Performance Status Deterioration [ Time Frame: Up to 36 months ]Median Time to Eastern Cooperative Oncology Group (ECOG) Performance status in deterioration. 0 - Fully active, able to carry on all pre-disease performance without restriction; 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2- Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 - Capable of limited self-care, confined to bed or chair more than 50% of waking hours; 4 - Completely disabled; cannot carry on any self-care; totally confined to bed or chair. Rate in black participants, non-black participants, and participants overall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415621
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Jesse Mocha 813-745-2629 firstname.lastname@example.org|
|Contact: Jingsong Zhang, M.D., Ph.D. 813-745-1363 email@example.com|
|Principal Investigator: Jingsong Zhang, M.D., Ph.D.|
|Sub-Investigator: Lodovico Balducci, M.D.|
|Sub-Investigator: Mayer Fishman, M.D., Ph.D.|
|Sub-Investigator: Julie Kish, M.D.|
|Sub-Investigator: Jae K. Lee, Ph.D.|
|Principal Investigator:||Jingsong Zhang, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|