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Steroidogenesis Inhibitor
Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer
Phase < 1
Waitlist Available
Led By Jingsong Zhang, M.D., Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (CRPC) patients on abiraterone with at least 50% decline of pre-treatment PSA
Prior surgical castration or concurrent use of gonadotropin-releasing hormone (GnRH) analogue with testosterone at screening <50 ng/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial will test whether an on and off schedule of taking abiraterone can prolong a cancer's response to the drug and help patients maintain their quality of life.
Who is the study for?
This trial is for men with metastatic castration-resistant prostate cancer who are minimally symptomatic and have seen a significant drop in PSA levels after standard abiraterone treatment. They should be able to perform daily activities, not require opioids for pain, and have no major health issues or recent surgeries.Check my eligibility
What is being tested?
The study tests if taking abiraterone on an intermittent schedule can extend the drug's effectiveness in controlling prostate cancer while maintaining patients' ability to carry out everyday tasks.See study design
What are the potential side effects?
Abiraterone may cause side effects like high blood pressure, heart problems, liver issues, digestive disturbances, difficulty swallowing tablets, and could potentially interfere with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is advanced but not causing major symptoms, and my PSA levels have dropped by at least 50% since starting abiraterone.
Select...
I have undergone surgical castration or am using hormone therapy with low testosterone levels.
Select...
I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostatic Specific Antigen (PSA) Response Rate
Secondary outcome measures
Median Radiographic Progression-Free Survival (rPFS)
Median Time to Performance Status Deterioration
Side effects data
From 2022 Phase 2 trial • 26 Patients • NCT0304380781%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
hematochezia
4%
elevated ALT
4%
xerostomia
4%
cough
4%
elevated AST
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Abiraterone Acetate TherapyExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,473 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,165 Patients Enrolled for Prostate Cancer
Jingsong Zhang, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
4 Previous Clinical Trials
54 Total Patients Enrolled
2 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or liver.I have had treatments like TAK-700, ketoconazole, radium 223, or up to 6 cycles of docetaxel.I haven't had treatment for another cancer within 2 years, except for non-melanoma skin cancer or carcinoma in situ that was completely removed.My prostate cancer is advanced but not causing major symptoms, and my PSA levels have dropped by at least 50% since starting abiraterone.I do not have severe heart problems like unstable angina, serious arrhythmias, or advanced heart failure.I do not have uncontrolled HIV, hepatitis B or C, or any serious illness that could affect my study participation.I don't have GI diseases or procedures that affect drug absorption.My prostate cancer diagnosis was confirmed through a tissue sample.My organs are functioning well.I haven't had any serious health issues or surgeries in the last 28 days.My high blood pressure is not controlled despite medication.I have undergone surgical castration or am using hormone therapy with low testosterone levels.I have wounds, ulcers, or bone fractures that are healing slowly.I stopped my prostate cancer treatments (except for bone treatments and hormone therapy) 3 weeks ago.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Abiraterone Acetate Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any existing investigations that support the efficacy of this particular intervention?
"Currently, 86 studies are being conducted on this particular therapy. 25 of these clinical trials have entered Phase 3 and the majority are based in Duarte, California with 6191 sites running experiments across the globe."
Answered by AI
How many people are being admitted as participants in this clinical trial?
"This experiment is not currently taking on new patients. It was initially posted in April 2015 and the last update was recorded in April 2023. Fortunately, there are 1,330 trials for prostate cancer that are still enrolling and 86 more experiments recruiting participants specifically for this treatment."
Answered by AI
Are there any current opportunities to partake in this research?
"According to the clinicaltrials.gov platform, this medical trial is no longer seeking candidates; although it was posted on April 13th 2015 and last updated on April 10th 2023, there are presently 1416 alternative studies currently recruiting individuals."
Answered by AI
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