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Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

NCT03777982 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-09-19

Study results available
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Summary

This research study is being offered to those patients who have received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose PSA remains detectable despite having received at least 6, but no more than 12 months of hormonal therapy.

The name of the study drugs involved in this study is:

* LHRHA (luteinizing hormone-releasing hormone agonist or antagonist)
* Abiraterone Acetate
* Apalutamide
* Prednisone

Conditions

Interventions

DRUG

Prednisone

Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.

DRUG

Apalutamide

Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.

DRUG

Abiraterone Acetate

Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself

DRUG

LHRH Agonist or Antagonist

Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles

Sponsors & Collaborators

Principal Investigators

  • Anthony D'Amico, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2024-02-13
Completion
2024-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777982 on ClinicalTrials.gov