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Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.

Primary Purpose

Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abiraterone Oral Tablet
Prednisone tablet
Drug Dairy/Log
Low-fat meal
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed prostate cancer with plans to initiate abiraterone acetate
  • Have never received prior abiraterone or other androgen receptor modulators, including enzalutamide, apalutamide, or darolutamide.
  • Must have a baseline DHEA-S level of >20 mg/dL (in order to adequately assess DHEA-S response)
  • A minimum washout of 28 days for any other anticancer therapy other than medical or surgical castration, prior to first dose of study drug is required.
  • Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug.
  • Denosumab or zoledronic acid are allowed.
  • Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix A).
  • Participants must have normal hepatic function as defined by clinical lab values set by the study doctor/research team.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease Prostate-Specific Antigen levels or any systemic corticosteroid (other than prednisone ≤10mg/day) within 4 weeks prior to first dose of study drug.
  • Inability to swallow capsules or known gastrointestinal malabsorption.
  • Blood pressure that is not controlled despite > 2 oral agents (SBP >160 and DBP >90 documented during the screening period with no subsequent blood pressure readings <160/100).
  • Serum K+ < 3.5 mmoL/L. Patients with a K+ < 3.5 mmoL/L are required to have a documented subsequent K+ >3.5 prior to enrollment to be eligible.
  • Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
  • Active psychiatric illness/social situations that would limit compliance with protocol requirements.
  • Serious heart issues/congestive heart failure as assessed by New York Heart Association's definition of class II, class III, or IV congestive heart failure.
  • Taking other medications or drugs with strong inhibitors or inducers of CYP3A4 (See Section 8.12 below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions with abiraterone.

Sites / Locations

  • University of Chicago Medicine Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: Dose Regimen 1

Group 2: Dose Regimen 2

Group 3: Dose Regimen 3

Group 4: Dose Regimen 4

Arm Description

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal every other day. You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1, day 3, day 5 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 and day 4 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.

Outcomes

Primary Outcome Measures

Change in DHEA-S Levels Among Participants at 4 Weeks
Efficacy of different dosing regimens of abiraterone 500 mg as assessed by decrease/reduction in serum dihydroepiadrosterone sulfate (DHEA-S) levels among participants at 4 weeks.

Secondary Outcome Measures

Change in Prostate-Specific Antigen (PSA) Levels of Participants at 12 Weeks
The effects of different dosing regimens of abiraterone 500 mg on serum as assessed by a reduction/decline in Prostate-Specific Antigen (PSA) levels (a 50% decline in PSA from baseline) at 12 weeks.
Rate of Adverse Events Reported Among Participants in Different Abiraterone Dosing Regimen Groups
Rate of adverse events reported among participants taking abiraterone 500 mg in different dosing groups as assessed by the Common Terminology Criteria for Adverse Events version 5.

Full Information

First Posted
March 2, 2022
Last Updated
August 28, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05276492
Brief Title
Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.
Official Title
Abiraterone Dose De-Escalation Study: A Prospective Study Evaluating Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2025 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Doctors leading this study plan to collect new information about the lowest effective dose of abiraterone acetate in study participants with prostate cancer who are taking abiraterone in combination with prednisone for the first time. The duration of this study will be about 3 months (12 weeks). How long you stay on abiraterone, and at what dose after completion of the 12 weeks of study drug administration, will be up to you and your treating physician.
Detailed Description
Doctors leading this study plan to collect new information about the lowest effective dose of abiraterone acetate in study participants with prostate cancer who are taking abiraterone in combination with prednisone for the first time. The duration of this study will be about 3 months (12 weeks). How long you stay on abiraterone, and at what dose after completion of the 12 weeks of study drug administration, will be up to you and your treating physician. Therefore, this study will evaluate if alternative dosing strategies with 500 mg pills may be equally effective as taking abiraterone 1000 mg daily. This study will specifically assess whether taking 500 mg of abiraterone every other day with a low-fat meal, or 500 mg with a low-fat meal at less frequent intervals (fewer times per week), is equally effective in treating prostate cancer as the 1000 mg/day dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Prostate Neoplasm, Prostate Cancer Metastatic
Keywords
prostate cancer, prostate adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Dose Regimen 1
Arm Type
Experimental
Arm Description
You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal every other day. You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.
Arm Title
Group 2: Dose Regimen 2
Arm Type
Experimental
Arm Description
You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1, day 3, day 5 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.
Arm Title
Group 3: Dose Regimen 3
Arm Type
Experimental
Arm Description
You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 and day 4 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.
Arm Title
Group 4: Dose Regimen 4
Arm Type
Experimental
Arm Description
You will be enrolled in the study based on the study group that is open at that particular time. If you are enrolled in this group, you will receive: - Abiraterone 500 mg and prednisone 5mg with a low-fat meal on day 1 of every week You will take 2 pills (500 mg total) of abiraterone acetate, first thing in the morning with breakfast. The tablets should be swallowed whole and not crushed, chewed, or dissolved in water. This breakfast should be a low-fat meal (avoid high calorie foods with a high percentage of fat, such as bacon or sausage). You will be asked to document the details of the meal/taking abiraterone in a daily log. You will also take prednisone 5 mg daily in the form of tablets taken by mouth with approximately 8 ounces of water with food. You do not have to take prednisone and abiraterone at the same time of day. If you inadvertently miss a dose of the study drug, you should take the dose the next day and record this on your Drug Diary.
Intervention Type
Drug
Intervention Name(s)
Abiraterone Oral Tablet
Other Intervention Name(s)
Yonsa, Zytiga
Intervention Description
Abiraterone is used in combination with prednisone to treat a certain type of prostate cancer that has spread to other parts of the body. Abiraterone is in a class of medications called androgen biosynthesis inhibitors. It works by decreasing the amount of certain hormones in the body.
Intervention Type
Drug
Intervention Name(s)
Prednisone tablet
Other Intervention Name(s)
Deltasone, Prednicot, Rayos, Sterapred, Sterapred DS
Intervention Description
Prednisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.
Intervention Type
Other
Intervention Name(s)
Drug Dairy/Log
Intervention Description
A drug dairy/log that will the study team will give for you to document information about the study drugs and meals you take during the study.
Intervention Type
Drug
Intervention Name(s)
Low-fat meal
Intervention Description
A low-fat meal that will be taken with abiraterone. If you have questions about what is considered "a low-fat" meal during the study, ask the study doctor or research staff.
Primary Outcome Measure Information:
Title
Change in DHEA-S Levels Among Participants at 4 Weeks
Description
Efficacy of different dosing regimens of abiraterone 500 mg as assessed by decrease/reduction in serum dihydroepiadrosterone sulfate (DHEA-S) levels among participants at 4 weeks.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Prostate-Specific Antigen (PSA) Levels of Participants at 12 Weeks
Description
The effects of different dosing regimens of abiraterone 500 mg on serum as assessed by a reduction/decline in Prostate-Specific Antigen (PSA) levels (a 50% decline in PSA from baseline) at 12 weeks.
Time Frame
12 weeks
Title
Rate of Adverse Events Reported Among Participants in Different Abiraterone Dosing Regimen Groups
Description
Rate of adverse events reported among participants taking abiraterone 500 mg in different dosing groups as assessed by the Common Terminology Criteria for Adverse Events version 5.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed prostate cancer with plans to initiate abiraterone acetate Have never received prior abiraterone or other androgen receptor modulators, including enzalutamide, apalutamide, or darolutamide. Must have a baseline DHEA-S level of >20 mg/dL (in order to adequately assess DHEA-S response) A minimum washout of 28 days for any other anticancer therapy other than medical or surgical castration, prior to first dose of study drug is required. Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug. Denosumab or zoledronic acid are allowed. Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix A). Participants must have normal hepatic function as defined by clinical lab values set by the study doctor/research team. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease Prostate-Specific Antigen levels or any systemic corticosteroid (other than prednisone ≤10mg/day) within 4 weeks prior to first dose of study drug. Inability to swallow capsules or known gastrointestinal malabsorption. Blood pressure that is not controlled despite > 2 oral agents (SBP >160 and DBP >90 documented during the screening period with no subsequent blood pressure readings <160/100). Serum K+ < 3.5 mmoL/L. Patients with a K+ < 3.5 mmoL/L are required to have a documented subsequent K+ >3.5 prior to enrollment to be eligible. Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled. Active psychiatric illness/social situations that would limit compliance with protocol requirements. Serious heart issues/congestive heart failure as assessed by New York Heart Association's definition of class II, class III, or IV congestive heart failure. Taking other medications or drugs with strong inhibitors or inducers of CYP3A4 (See Section 8.12 below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions with abiraterone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Clinical Trials Intak
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Szmulewitz, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Intake
Phone
855-702-8222
Email
cancerclinicaltrials@bsd.uchicago.edu

12. IPD Sharing Statement

Learn more about this trial

Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose.

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