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History of Changes for Study: NCT02415621
Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
Latest version (submitted November 10, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2015 None (earliest Version on record)
2 April 15, 2015 Study Status and Study Identification
3 September 22, 2015 Study Status and Contacts/Locations
4 February 29, 2016 Contacts/Locations, Study Status and Eligibility
5 March 24, 2016 Contacts/Locations and Study Status
6 August 22, 2016 Study Description, Study Status and Contacts/Locations
7 December 28, 2016 Arms and Interventions and Study Status
8 February 6, 2017 Study Status
9 July 28, 2017 Study Status, Study Design and Study Description
10 December 12, 2017 Study Status, Contacts/Locations and Study Design
11 February 5, 2018 Study Status
12 June 14, 2018 Study Status and Contacts/Locations
13 November 1, 2018 Study Status
14 April 1, 2019 Study Status
15 September 6, 2019 Study Status
16 November 5, 2019 Contacts/Locations and Study Status
17 January 13, 2020 Study Status
18 January 13, 2020 Recruitment Status, Study Status and Contacts/Locations
19 February 5, 2020 Study Status
20 February 24, 2020 Recruitment Status, Study Status and Study Design
21 July 6, 2020 Study Status
22 August 31, 2020 Study Status and Study Design
23 December 2, 2020 Study Status
24 May 21, 2021 Study Status
25 October 11, 2021 Study Status
26 January 28, 2022 Study Status
27 June 21, 2022 Study Status
28 November 10, 2022 Study Status
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Study NCT02415621
Submitted Date:  April 9, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: MCC017981
Brief Title: Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
Official Title: A Pilot Study of Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: April 2015
Primary Completion: April 2018 [Anticipated]
Study Completion:
First Submitted: April 9, 2015
First Submitted that
Met QC Criteria:
April 9, 2015
First Posted: April 14, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 9, 2015
Last Update Posted: April 14, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:

In this pilot study, 20 black participants and 20 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, subjects 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.

Open or close this module Conditions
Conditions: Prostate Cancer
Keywords: metastatic
castration resistant
abiraterone therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Abiraterone Acetate Therapy
Study schedule involves stopping 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 Names:
  • Zytiga
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. 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.
2. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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 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

Exclusion Criteria:

  • 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
Open or close this module Contacts/Locations
Study Officials: Jingsong Zhang, M.D., Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Locations: United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
[Recruiting]
Tampa, Florida, United States, 33612
Contact:Contact: Inez Sims 813-745-3982 inez.sims@moffitt.org
Contact:Principal Investigator: Jingsong Zhang, M.D., Ph.D.
Contact:Sub-Investigator: Lodovico Balducci, M.D.
Contact:Sub-Investigator: Mayer Fishman, M.D., Ph.D.
Contact:Sub-Investigator: Robert Gatenby, M.D.
Contact:Sub-Investigator: Shilpa Gupta, M.D.
Contact:Sub-Investigator: Julie Kish, M.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Moffitt Cancer Center Clinical Trials website
Available IPD/Information:

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