Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

NCT02415621 | Active Not Recruiting Early Phase 1

• 1 other identifier: MCC-17981
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

metastatic; castration resistant; abiraterone therapy

Outcome Measures

Primary Outcomes (1)

• Prostatic Specific Antigen (PSA) Response Rate

  PSA response rate (defined as 50% decline of pre abiraterone PSA) at cycle 2. Rate in black participants, non-black participants, and participants overall.

  End of cycle 2: 2 months per participant

Secondary Outcomes (2)

• Median Radiographic Progression-Free Survival (rPFS)

  Up to 36 months

• Median Time to Performance Status Deterioration

  Up to 36 months

Study Arms (1)

Abiraterone Acetate Therapy

OTHER

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

Interventions

Abiraterone Acetate DRUG

1000 mg by mouth (PO) every day (QD)

Also known as: Zytiga

Abiraterone Acetate Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate (the availability archival prostate tumor sample is preferred not required)
• Asymptomatic or minimally symptomatic (not requiring opioids for cancer related pain) metastatic castration resistant prostate cancer (CRPC) patients on abiraterone as standard of care and achieved at least 50% decline of their pre-treatment prostatic specific antigen (PSA)
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• Adequate organ function
• Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment
• Prior surgical castration or concurrent use of gonadotropin-releasing hormone (GnRH) analogue (i.e. medical castration) with testosterone at screening \<50 ng/dL.
• Ability to give written informed consent

You may not qualify if:

• Except GnRH analogue therapy, any other therapies for prostate cancer (excluding bisphosphonate and denosumab) must be discontinued 3 weeks before the first dose of study drugs.
• Prior treatments with Cyp 17 inhibitors like TAK-700/Orteronel, ketoconazole, radium 223 or docetaxel (up to 6 cycles of docetaxel given in the non CRPC setting is allowed). Prior treatment with Sipuleucel-T is allowed.
• Documented central nervous system (CNS) metastases or liver metastasis
• Treatment with any investigational compound within 30 days prior to the first dose of study drugs
• Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy \& have any evidence of residual disease. Potential participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening period). Note: May be rescreened after adjustments of antihypertensive medications
• Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 \[National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03\], New York Heart Association (NYHA) Class III or IV heart failure
• Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study.
• Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables
• Delayed healing of wounds, ulcers, and/or bone fractures
• Inability to comply with protocol requirements

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Zhang J, Cunningham JJ, Brown JS, Gatenby RA. Integrating evolutionary dynamics into treatment of metastatic castrate-resistant prostate cancer. Nat Commun. 2017 Nov 28;8(1):1816. doi: 10.1038/s41467-017-01968-5.

  PMID: 29180633 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jingsong Zhang, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: April 13, 2015
• Primary Completion: August 12, 2019
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)