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Hormone Therapy

ADT with or without Docetaxel for Prostate Cancer

Phase 2

Waitlist Available

Led By Sarah Fenton, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed PCa and imaging evidence of metastatic disease on CT, MRI, and/or bone scan. A PSMA PET scan may be used, but findings confirming metastatic disease (ex. A lymph node > 1 cm or a bone lesion) must be observed on the CT portion of the scan.

Patients must have low volume metastatic disease per the CHAARTED [1, 2] criteria; Low volume is defined as metastasis in lymph nodes outside of the pelvis and/or boney lesions (< 4 boney lesions, none outside of the axial skeleton). No visceral metastasis allowed. Metastatic disease must be documented either by a positive bone scan, contrast-enhanced abdominal/pelvic/chest computed tomography (CT) scan, magnetic resonance imaging scan or a prostate-specific membrane antigen (PSMA) PET scan. If a PSMA PET scan is used, the CT portion must confirm lymph node enlargement > 1cm or evidence of sclerosis for boney lesions. Metastatic disease is defined as either malignant lesions in the bone and/or measurable lymph nodes above the aortic bifurcation. Only patients with non-regional lymph node metastases (M1a) and/or bone metastases (M1B) will be eligible.

Must not have

Patients with history of or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Second generation ARPIs such as enzalutamide, ARN-509, abiraterone, other investigational AR inhibitors.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (+/- 30 days) after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if 1st line therapy w/ ADT+abiraterone (doublet arm) or ADT+abiraterone+docetaxel (triplet arm) is better for low volume mHSPC patients.

Who is the study for?

Men with low volume metastatic hormone-sensitive prostate cancer who have started androgen deprivation therapy within the last 12 weeks. They must be in good physical condition (ECOG ≤1), have proper organ and bone marrow function, understand the study, and consent to participate. No prior chemotherapy for prostate cancer is allowed, except as specified.

What is being tested?

This trial compares two treatments: ADT + abiraterone versus ADT + abiraterone + docetaxel for first-line therapy in men with low volume mHSPC. It's a phase II study where patients are randomly assigned to one of these treatment arms to see which provides better outcomes.

What are the potential side effects?

Possible side effects include fatigue, allergic reactions to drugs, liver issues due to abiraterone, hair loss from docetaxel, blood cell count changes leading to increased infection risk or bleeding problems, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread, confirmed by scans.

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My cancer has spread to a few bones or lymph nodes but not to my organs.

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I have had radiation for my brain metastases as per standard care.

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I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

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

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My hepatitis B is under control with treatment.

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I have not taken drugs like enzalutamide or abiraterone for my condition.

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I haven't had a stroke, heart attack, severe chest pain, heart surgery, or heart failure in the last 6 months.

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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.

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I am HIV positive, on stable treatment, with an undetectable viral load and CD4 count ≥ 200.

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I am not taking strong CYP3A4 inhibitor medications.

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I have not had major surgery in the last 30 days.

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I cannot have CT or MRI scans with contrast due to allergies or other reasons.

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I am taking medication like abiraterone or ketoconazole for prostate cancer.

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My high blood pressure is not controlled, even with medication.

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I can take pills and don't have major stomach or bowel issues affecting drug absorption.

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I have chronic liver disease that requires treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (+/- 30 days) after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (+/- 30 days) after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (+/- 30 days) after randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess Progression Free Survival (PFS)

Secondary study objectives

Assess Overall Survival (OS)

Assess PSA Response Rate

Assess time to compare for any difference in efficacy between arms

+1 more

Other study objectives

Assess Quality of Life (QoL)

Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Triplet ArmExperimental Treatment3 Interventions

Abiraterone+Docetaxel+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion. ADT Patients may be started on an LHRH agonist or antagonist , the selection of the agent is left to the treating investigator for ADT.

Group II: Doublet ArmActive Control2 Interventions

Abiraterone+ADT Abiraterone Abiraterone acetate will be four (250 mg) tablets (total dose/day 1000 mg). Abiraterone administration is per a 12-week cycle. Treatment of abiraterone should start ≤14 days after patient randomization. Abiraterone must be taken with prednisone. Prednisone will be provided as 5 mg tablets. Docetaxel Docetaxel on day 1 of each 21-day cycle, 75 mg/m2 via IV. Prior to docetaxel, dexamethasone administration is recommended as discussed, but can be adjusted or altered per the treating investigator's discretion. Dexamethasone will be self-administered by the patient at 16 mg per day for 3 days starting 1 day prior to docetaxel infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

ADT

2009

Completed Phase 3

~5120