Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Vasoconstrictor Agents

Respiratory System Agents

Anti-Inflammatory Agents

Androgens

Hormones

Abiraterone Acetate

Epinephrine

Prednisone

Testosterone

Prolactin Release-Inhibiting Factors

Imidacloprid

Racepinephrine

Epinephryl borate

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

-LHRH agonist or antagonist should be prescribed per standard of care

* LHRH agonist or antagonist should be prescribed per standard of care
* Abiraterone acetate will be taken once daily
* Prednisone will be taken twice daily
* Apalutamide will be taken once daily

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

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

Apalutamide

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

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

LHRH Agonist or Antagonist

Anthony D'Amico, MD, PhD

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

This research study is a Phase III clinical trial. Phase III clinical trials test the effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that an intervention is being studied. In this study, the investigational agents are apalutamide and abiraterone acetate. Abiraterone acetate (used in combination with prednisone) is an FDA (the U.S. Food and Drug Administration) approved drug for prostate cancer, but is approved in patients that have prostate cancer spread to other parts of their body and have been previously treated with ADT. Apalutamide has also been approved by the FDA for men whose cancer does not respond to hormone therapy but it is still investigational for this type of cancer.

In this research study, the investigators are looking at two methods of androgen deprivation therapy (ADT), also known as hormonal therapy, to determine which method is better for improving long term cure rates. ADT blocks the function of hormones, including testosterone which prostate cancer uses to grow and spread. The first method of ADT includes prednisone, apalutamide, and abiraterone acetate plus standard ADT and the second method of ADT is standard ADT alone for men with this type of prostate cancer. Currently, the best standard treatment for men with this type of prostate cancer includes standard ADT. All participants in this study will receive the main standard form of ADT called a luteinizing hormone-releasing hormone agonist or antagonist (LHRHA).

Conventional ADT w/ or w/Out Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor-Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

the composite of metastasis or any cause death

PSA nadir is defined as the lowest PSA after RT completion

Castrate resistant PSA failure is defined as the first PSA increase that is ≥ 25% and 2 ng/mL above the nadir, which is confirmed by a second value 3 or more weeks later, while the serum total testosterone level is \< 50 ng/dl (per the PCWG2 criteria).

Prostate cancer specific survival is defined the time from randomization to death from prostate cancer where death due to other causes are considered as competing risk, or censored at the last date of follow up in living patients.

Overall survival is defined as the time from randomization to death from any cause with men censored at time of last follow up if alive.

Disease free survival is measured from the date of randomization to the first recorded disease recurrence consisting of castrate resistant PSA failure and/or local, regional or distant failure and death from any cause, whichever comes first, or censored at the date of last disease assessment for those alive and disease recurrence free.

We will measure Grade 1-5 toxicities at study visits and follow-up using the CTCAE v.5 forms and determine attribution.

Spots Global Cancer Trial Database for lhrh agonist or antagonist