← Back to Search

Anti-tumor antibiotic

Androgen Deprivation + Docetaxel for Prostate Cancer

Tampa, FL

Phase 2

Recruiting

Led By Jingsong Zhang, MD, PhD

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

Biopsy proven prostate cancer

Achieved >50% PSA decline and <4 ng/ml PSA after the run-in period

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)

Surgical castration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a combination of adaptive androgen deprivation therapy (ADT) and Docetaxel can help in extending the period of time before prostate cancer becomes resistant to treatment.

See full description

Who is the study for?

This trial is for men with stage IV prostate cancer that still responds to hormone therapy. Participants should not have had previous chemotherapy for metastatic disease and must be fit enough for Docetaxel treatment. They cannot join if they have allergies that would affect the study or if they've received certain other cancer treatments.Check my eligibility

What is being tested?

The study is testing a combination of hormone-blocking drugs (LHRH analogs and ARSI) with a chemotherapy drug called Docetaxel, aiming to extend the time the cancer remains sensitive to hormone therapy.See study design

What are the potential side effects?

Possible side effects include hot flashes, fatigue, nausea, hair loss from chemotherapy, and potential allergic reactions. Hormone therapy can also cause decreased libido and bone thinning.

Eligibility Criteria

Inclusion Criteria

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

Select...

My prostate cancer was confirmed by a biopsy.

show original

Select...

My PSA levels dropped by more than 50% and are now below 4 ng/ml.

show original

Select...

I am fully active or can carry out light work.

show original

Select...

My blood counts and kidney/liver function tests are within normal ranges.

show original

Exclusion Criteria

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

Select...

I am allergic to certain cancer drugs or their ingredients.

show original

Select...

I have undergone surgical castration.

show original

Select...

I have previously been treated with TAK-700, abiraterone, apalutamide, or enzalutamide.

show original

Select...

My cancer has spread to my liver or brain.

show original

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Castration Sensitivity Rate

Secondary study objectives

On treatment PSA Progression Free Survival

Overall Survival

Patient Reported Outcome

+1 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: Adaptive Androgen Deprivation and Docetaxel TreatmentExperimental Treatment3 Interventions

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~7060

0 / 9Eligibility criteria met