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Hormone Therapy

Androgen Deprivation Therapy for Advanced Prostate Cancer

Phase < 1

Waitlist Available

Led By Jingsong Zhang, M.D., Ph.D.

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

Histologically or cytologically confirmed adenocarcinoma of the prostate

Adequate organ function: Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be < 2.5 x upper limit of normal (ULN), total bilirubin less than 1.5 X ULN, estimated creatinine clearance must be >40 mL/min, absolute neutrophil count (ANC) > 1500/l, hemoglobin above 9 g/dl, platelet count > 100,000/l

Must not have

Prior treatments with TAK-700/Orteronel, ketoconazole, apalutamide or enzalutamide

Documented central nervous system metastases or liver metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months from participant's first dose of adt

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for advanced prostate cancer that may be more effective than the current standard of care.

Who is the study for?

Men with advanced prostate cancer that responds to initial hormone therapy can join. They must be in good physical shape (ECOG 0-1), have normal organ function, and no serious health issues or surgeries in the last month. Excluded are those who've had certain treatments for prostate cancer, uncontrolled high blood pressure, severe heart problems, GI diseases affecting drug absorption, brain or liver metastases, another recent cancer diagnosis or treatment.

What is being tested?

The trial is testing Adaptive Androgen Deprivation Therapy (ADT) combined with standard care including abiraterone and prednisone. The goal is to see if this adaptive approach better controls high-risk metastatic castration-sensitive prostate cancer compared to traditional methods.

What are the potential side effects?

Possible side effects include fatigue, hot flashes from ADT; increased blood sugar and bone thinning from prednisone; and liver function changes, fluid retention, and hypertension from abiraterone. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer was confirmed by a lab test.

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My liver, kidney, and blood tests are within normal ranges.

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I am fully active or can carry out light work.

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My PSA levels dropped by more than 75% after treatment with GnRH analog, abiraterone, and prednisone.

Exclusion Criteria

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

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

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My cancer has spread to my brain or liver.

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I have been treated with GnRH analog for prostate cancer within the last year or for more than 3 months if it has spread.

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I need opioids to manage my cancer pain.

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I do not have severe heart problems like unstable angina, serious arrhythmias, or advanced heart failure.

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I do not have HIV, hepatitis B or C, or any serious illness that could interfere with the study.

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I have undergone surgical castration.

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I don't have GI conditions that affect drug absorption or can't swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months from participant's first dose of adt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months from participant's first dose of adt

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months from participant's first dose of adt for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of Participant Retention

Secondary study objectives

Median Time to Progression From the First Dose of Androgen Deprivation Therapy (ADT)

Median Time to Radiographic Progression From the First Dose of ADT

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 ADT+ Standard of CareExperimental Treatment3 Interventions

Participants will undergo 12-16 weeks of GnRH analog, along with 8-12 weeks of combinational therapy with GnRH analog and abiraterone plus prednisone. 14 participants who achieve \>75% PSA decline after the run-in period will be enrolled. GnRH analog and abiraterone will be stopped after study enrollment. PSA and testosterone level will be measured every 4 weeks during the run-in period, then every 6 weeks after study enrollment. Imaging studies with CT and bone scan will be performed at the time of study enrollment and these will be considered baseline scans. Study treatment will be restarted if participant's PSA reaches 2 fold or higher of his baseline PSA. Selection of treatment will be based on participant's testosterone level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone

2012

Completed Phase 4

~4480

Prednisone

2014

Completed Phase 4

~2500