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Antiandrogen Therapy
ChemoHormonal Therapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Julie N Graff
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Definition 2: >=4 bone lesions, including >=1 outside of the vertebral column or pelvis and/or visceral metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat men with high-risk prostate cancer that hasn't responded to other treatments. The drugs work by blocking testosterone, which can cause the cancer to grow.
Who is the study for?
Men with high-risk, treatment-naive metastatic prostate cancer that is sensitive to hormone therapy are eligible. They must have completed up to 6 cycles of docetaxel chemotherapy and meet specific criteria including a PSA > 50 ng/mL, certain levels of disease spread, and no prior second-generation antiandrogen therapies. Participants need good organ function, controlled blood pressure without certain medications, no active infections like HIV or hepatitis, and agree to use contraception.Check my eligibility
What is being tested?
The trial tests the effectiveness of combining apalutamide, abiraterone acetate, and prednisone after chemotherapy in men with advanced prostate cancer. It also investigates genetic factors related to prostate cancer inheritance. The goal is to see if this combination works better for those who haven't had previous treatments and whose cancer still responds to hormone therapy.See study design
What are the potential side effects?
Possible side effects include fatigue; digestive issues; changes in blood pressure; liver problems; increased risk of infections due to immune suppression from prednisone; potential hormonal imbalances leading to mood swings or weight gain; skin reactions from antiandrogen therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have more than 4 bone lesions, with at least one outside my spine or pelvis, or I have cancer that has spread to my organs.
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I can take care of myself but might not be able to do heavy physical work.
Select...
I have confirmed or strongly suspected prostate cancer with a PSA level over 50 ng/mL.
Select...
My cancer diagnosis includes at least 2 of these: spread to organs, 3+ bone lesions, or high Gleason score.
Select...
I stopped taking any medication that could increase my risk of seizures 4 weeks ago.
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It's been over 24 months since I last used hormone therapy for my cancer before it spread.
Select...
My kidney function, measured by eGFR, is above 30 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete prostate specific antigen (PSA) response
Secondary outcome measures
Incidence of adverse events >= grade 2
Overall survival
Proportion of patients with PSA response >= 50% decrease
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (apalutamide, abiraterone acetate, prednisone, ADT)Experimental Treatment8 Interventions
Patients receive apalutamide PO QD, abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo CT scan, bone scan and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1730
Abiraterone Acetate
2015
Completed Phase 4
~1880
Apalutamide
2015
Completed Phase 2
~3310
Antiandrogen Therapy
2015
Completed Phase 1
~10
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,719 Total Patients Enrolled
27 Trials studying Prostate Cancer
2,433 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,511 Total Patients Enrolled
11 Trials studying Prostate Cancer
1,343 Patients Enrolled for Prostate Cancer
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,022 Total Patients Enrolled
21 Trials studying Prostate Cancer
7,366 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have more than 4 bone lesions, with at least one outside my spine or pelvis, or I have cancer that has spread to my organs.I am not taking specific drugs that don't mix well with the trial medication.I can take care of myself but might not be able to do heavy physical work.Patients must have a condition that is considered to be high risk for the study.I've finished up to 6 rounds of docetaxel for my metastatic cancer within the last 16 weeks.I have had a seizure or a condition that could lead to seizures, like a recent stroke.I have confirmed or strongly suspected prostate cancer with a PSA level over 50 ng/mL.I am willing to stop taking saw palmetto or other similar herbal supplements.I don't have uncontrolled high blood pressure, absorption issues, active infections like HIV, need for high-dose steroids, or any condition that would stop me from joining this study.My prostate cancer has not worsened since starting hormone therapy.I have previously been treated with advanced prostate cancer medications.My cancer diagnosis includes at least 2 of these: spread to organs, 3+ bone lesions, or high Gleason score.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.I cannot stop taking certain medications like antipsychotics or antidepressants.I have another cancer besides non-dangerous skin or superficial bladder cancer.I have taken certain prostate cancer medications but will stop before the study starts.You are expected to live for more than 18 months.I am not taking strong medications that affect liver enzymes with my cancer treatment.I haven't had serious heart issues or blood clots in the last 6 months.It's been over 24 months since I last used hormone therapy for my cancer before it spread.My kidney function, measured by eGFR, is above 30 mL/min.You have had allergic reactions to drugs that are similar to apalutamide or other drugs being used in the study.My liver function is moderately to severely impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (apalutamide, abiraterone acetate, prednisone, ADT)
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.
What deleterious effects can be caused by Antiandrogen Therapy?
"Our experts at Power gave Antiandrogen Therapy a rating of 2, as there is evidence backing its safety but not yet any data to suggest its efficacy."
Answered by AI
Is this trial still recruiting participants?
"Affirmative, the details on clinicaltrials.gov point to this trial being open for recruitment now. It was first published in May of 2020 and last updated on July 6th 2022, with 76 participants needed from a single centre."
Answered by AI
In what cases is Antiandrogen Therapy typically employed?
"Antiandrogen Therapy is regularly used for scalp structure and may be prescribed to address thyroiditis, prostate cancer that has not spread, and ulcerative colitis."
Answered by AI
What precedent has been set for Antiandrogen Therapy in past research?
"Currently, there are 458 active scientific investigations into Antiandrogen Therapy with 129 trials in their final stage. Though the majority of these studies take place near Duarte, California, a total of 19628 sites host clinical research focused on this treatment."
Answered by AI
What is the current tally of participants in this experiment?
"Affirmative. Clinicaltrials.gov confirms that this research study, which was initially listed on May 11th 2020, is currently recruiting volunteers. A total of 76 individuals must be sourced from a single medical facility."
Answered by AI
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