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Hormone Therapy

ADT with or without Docetaxel for Prostate Cancer

Phase 2

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess Progression Free Survival (PFS)

Secondary outcome measures

Assess Overall Survival (OS)

Assess PSA Response Rate

Assess time to compare for any difference in efficacy between arms

+1 more

Other outcome measures

Assess Quality of Life (QoL)

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

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

ADT

2009

Completed Phase 3

~5120

Docetaxel

1995

Completed Phase 4

~5620

Abiraterone

2012

Completed Phase 4

~2830

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,976 Total Patients Enrolled

19 Trials studying Prostate Cancer

2,809 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,652 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,945 Patients Enrolled for Prostate Cancer

Sarah Fenton, MD, PhDPrincipal InvestigatorNorthwestern University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Triplet Arm regimen a secure option for individuals?

"The Triplet Arm protocol has been assessed at a safety level of 2, since the trial is currently in its Phase 2 stage and there are some data showcasing the drug's safety but none that proves efficacy."

Answered by AI

Is there currently an opportunity to join this research trial?

"As per clinicaltrials.gov, this medical trial is not recruiting participants at the present time. The research was initially made available on December 22nd 2023 and underwent its last change on September 27th 2023. Although no longer enrolling patients for this particular study, there are 1356 other experiments actively seeking volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone

2023. "Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060587.