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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

Must not have

Either of the following: Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)

Subjects who are unwilling to stop taking saw palmetto, PC-SPECs or other herbal agents known to affect the PSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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I have confirmed or strongly suspected prostate cancer with a PSA level over 50 ng/mL.

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My cancer diagnosis includes at least 2 of these: spread to organs, 3+ bone lesions, or high Gleason score.

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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.

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My kidney function, measured by eGFR, is above 30 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a seizure or a condition that could lead to seizures, like a recent stroke.

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I am willing to stop taking saw palmetto or other similar herbal supplements.

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I have previously been treated with advanced prostate cancer medications.

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I haven't had serious heart issues or blood clots in the last 6 months.

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I have another cancer besides non-dangerous skin or superficial bladder cancer.

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My liver function is moderately to severely impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete prostate specific antigen (PSA) response

Secondary study objectives

Incidence of adverse events >= grade 2

Overall survival

Proportion of patients with PSA response >= 50% decrease

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~2790

Biospecimen Collection

2004

Completed Phase 3

~2030

Bone Scan

2015

Completed Phase 2

~50

Abiraterone Acetate

2015

Completed Phase 4

~1880

Apalutamide

2015

Completed Phase 2

~5750

Antiandrogen Therapy

2015

Completed Phase 1

~10

Prednisone

2014

Completed Phase 4

~2500

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor

236 Previous Clinical Trials

2,089,565 Total Patients Enrolled

17 Trials studying Prostate Cancer

579 Patients Enrolled for Prostate Cancer

Janssen Scientific Affairs, LLCIndustry Sponsor

164 Previous Clinical Trials

579,792 Total Patients Enrolled

11 Trials studying Prostate Cancer

957 Patients Enrolled for Prostate Cancer

Oregon Health and Science UniversityOTHER

1,008 Previous Clinical Trials

7,414,182 Total Patients Enrolled

14 Trials studying Prostate Cancer

5,776 Patients Enrolled for Prostate Cancer

Julie N GraffPrincipal InvestigatorOHSU Knight Cancer Institute

1 Previous Clinical Trials

37 Total Patients Enrolled

Julie Graff, MD5.02 ReviewsPrincipal Investigator - OHSU Knight Cancer Institute

OHSU Knight Cancer Institute

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Prostate Cancer

60 Patients Enrolled for Prostate Cancer

5Patient Review

I have been a prostate cancer patient of Dr. Graff's for six years now and I have the utmost confidence in her knowledge of the field of cancer treatment and her genuine concern for me as a patient of hers. We discuss each stage of my disease and treatments and always my views are considered. I am currently in remission and living a full and satisfying life.

Alexandra Sokolova, M.D.Principal InvestigatorOHSU Knight Cancer Institute

1 Previous Clinical Trials

36 Total Patients Enrolled