Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03511196|
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Stage IV Prostate Cancer Advanced Prostate Cancer Adenocarcinoma of the Prostate||Drug: Adaptive Androgen Deprivation Therapy (ADT) Drug: Abiraterone Drug: Prednisone||Early Phase 1|
Investigators proposed this pilot feasibility study to use prostate specific antigen (PSA) response and testosterone level to guide the treatment with androgen deprivation therapy (ADT) [Leuprolide, Goserelin, and Triptorelin are the most commonly used GnRH agonists for ADT] and/or abiraterone plus prednisone. Adaptive therapy is a program of chemotherapy where the type and dosage of drug changes in an attempt to kill more of the cancer.
Abiraterone acetate with prednisone is a standard of care treatment for mCRPC (metastatic castration resistant prostate cancer). It works by interrupting the male hormone (androgen) making process in the testes, adrenal glands, and tumors. This helps to prevent the growth of tumors that need these hormones to grow.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Adaptive Androgen Deprivation Therapy for State IV Castration Sensitive Prostate Cancer|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Adaptive ADT+ Standard of Care
Participants will undergo 12-16 weeks of GnRH analog, along with 8-12 weeks of combinational therapy with GnRH analog and abiraterone plus prednisone. 14 participants who achieve >75% PSA decline after the run-in period will be enrolled. GnRH analog and abiraterone will be stopped after study enrollment. PSA and testosterone level will be measured every 4 weeks during the run-in period, then every 6 weeks after study enrollment. Imaging studies with CT and bone scan will be performed at the time of study enrollment and these will be considered baseline scans. Study treatment will be restarted if participant's PSA reaches 2 fold or higher of his baseline PSA. Selection of treatment will be based on participant's testosterone level.
Drug: Adaptive Androgen Deprivation Therapy (ADT)
ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.
Other Name: GnRH agonist
Prednisone 5 mg once a day with food.
Abiraterone 1000 mg daily with empty stomach.
- Rate of Participant Retention [ Time Frame: 12 months from participant's first dose of ADT ]Percentage of participants who remain on study at month 12. The study will be terminated early if 2 or more of the first 6 enrolled subjects discontinued study due to cancer progression within a year of study enrollment.
- Median Time to Progression From the First Dose of Androgen Deprivation Therapy (ADT) [ Time Frame: 12 months from participant's first dose of ADT ]Median time to prostate specific antigen (PSA) progression while on androgen deprivation therapy (ADT), abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
- Median Time to Radiographic Progression From the First Dose of ADT [ Time Frame: 12 months from participant's first dose of ADT ]Median time to radiographic progression while on ADT, abiraterone and prednisone. Progression is per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and the Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
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): NCT03511196
|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 813-745-1363 email@example.com|
|Principal Investigator: Jingsong Zhang, M.D., Ph.D.|
|Sub-Investigator: Alexander Anderson, PhD|
|Sub-Investigator: Julie Kish, MD, FACP|
|Sub-Investigator: Manish Kohli, MD|
|Principal Investigator:||Jingsong Zhang, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|