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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Rate of Participant Retention

Secondary outcome measures

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

Median Time to Radiographic Progression From the First Dose of ADT

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

Prednisone

2014

Completed Phase 4

~2370

Abiraterone

2012

Completed Phase 4

~2830

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,475 Total Patients Enrolled

27 Trials studying Prostate Cancer

4,167 Patients Enrolled for Prostate Cancer

Jingsong Zhang, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

4 Previous Clinical Trials

56 Total Patients Enrolled

2 Trials studying Prostate Cancer

29 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03511196 — Phase < 1

Prostate Cancer Research Study Groups: Adaptive ADT+ Standard of Care

Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT03511196 — Phase < 1

Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03511196 — Phase < 1

Frequently Asked Questions

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

Has Adaptive Androgen Deprivation Therapy (ADT) been investigated elsewhere?

"At this moment in time, 407 clinical trials are presently running research into Adaptive Androgen Deprivation Therapy (ADT); 110 of them being at the Phase 3 stage. These studies chiefly take place in Duarte, California, though there are a total of 18713 sites that offer this particular treatment option."

Answered by AI

Are there still enrollments available for the research project?

"Clinical trials.gov lists this trial as no longer recruiting patients, with the original post being released on September 17th 2018 and last updated November 2nd 2022. However, there are 1966 other medical studies still actively searching for participants at present."

Answered by AI

What maladies are generally addressed with Adaptive Androgen Deprivation Therapy (ADT)?

"Thyroiditis is frequently managed through Adaptive Androgen Deprivation Therapy (ADT). This same technique can also be employed to combat ulcerative colitis, certain forms of cancer, and varicella-zoster virus acute retinal necrosis."

Answered by AI

What is the overall participant count of this experiment?

"This trial is not currently accepting applications. It was initially published on the 17th of September 2018 and last updated in November 2022. If you wish to explore other options, 1559 clinical trials are available for patients with prostate cancer while 407 studies offer Adaptive Androgen Deprivation Therapy (ADT)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer

2018. "Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03511196.

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