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

Anti-Inflammatory Agents

Androgens

Hormones

Abiraterone Acetate

Prednisone

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

All subjects will receive abiraterone acetate and prednisone, as per standard of care. Abiraterone acetate will be administered orally as 1000 mg once daily along with 5 mg of oral prednisone twice per day. Subjects will continue to take abiraterone acetate and prednisone until confirmed disease progression.

1000 mg orally daily until disease progression

5 mg oral low dose prednisone, twice daily

Martha Mims, MD, PhD

Carolyn Thibodeaux, BS

Nicholas Mitsiades, MD, PhD

Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor

Anita Sabichi, MD

The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.

This is a single arm study in metastatic hormone naïve prostate cancer. Standard of care in these men is either to offer Androgen deprivation therapy (ADT) + abiraterone acetate/low-dose prednisone or, in men with higher tumor burden, to offer ADT + Docetaxel/prednisone. The investigator's experience is that even men with increased tumor burden often opt for abiraterone because of the improved side effect protocol as compared to chemotherapy.

Approximately 130 PSA response evaluable subjects will be enrolled, of which the investigators expect 50% to be African American based on clinic population and previous experience with clinical trial enrollment.

The study will enroll men with newly diagnosed hormone naïve prostate cancer within 42 days of receiving the first dose of ADT (LHRH agonist) or undergoing orchiectomy. Patients will continue ADT throughout the study. Abiraterone acetate and low dose prednisone will continue until progression as defined by standard PCWG2 criteria.

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer

Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer

We do not plan to share IPD with other researchers.

The proportion of subjects with PSA levels less than 4 ng/ml at the given time point.

Measure of the absolute amount of change in PSA levels, or measure of proportional change in PSA levels.

Number of potentially deleterious polymorphisms in proteins involved in androgen metabolism, stratified by race/ethnicity.

Measure of time until disease progression.

Measure of time until start of subsequent prostate cancer therapy.

Measure of time until start of chemotherapy.

Martha Mims

Professor, Medicine - Hematology and Oncology

Reproductive Control Agents

Leuprolide

Goserelin

Triptorelin Pamoate

Androgen Antagonists

Androgen Receptor Antagonists

The standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.

This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.

ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.

Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.

Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.

ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.

ODM-201

ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.

This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.

Bertrand Tombal, Pr

This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control.

The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.

In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm.

ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 milligrams (mg) (2 x 300-mg tablets) twice daily (bid) for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.

Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.

Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.

The standard treatment for this stage of the disease is androgen deprivation therapy (ADT) by means of Luteinizing hormone-releasing hormone (LHRH) antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.

This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.

The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.

The secondary objectives are to:

* To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on the Hormonal treatment (HTR) symptom scale of EORTC QLQ PR25 at 24 weeks;
* To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on EORTC QLQ C30 and PR25 at 24 weeks;
* To document the effect of ODM-201 on PSA complete response at 24 weeks (defined as ≥ 90% reduction from baseline);
* To document the effect of ODM-201 on objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline;
* To document the safety and tolerability of ODM-201 vs. ADT in subjects who have not previously received hormone treatment for prostate cancer;
* To document the effects of ODM-201 on androgen deprivations symptoms using the Aging male symptoms (AMS) questionnaires;
* To document the proportion of patients who opted to continue treatment with ODM-201 beyond the protocolized 24 weeks

The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.

Key secondary endpoints:

* Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.
* Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline
* PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline
* Safety according to National Cancer Institute - Common terminology for adverse events (NCI-CTC) version 4.0

ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

A Phase 2 Randomized Open-Label Study of Oral Darolutamide (ODM-201) vs. Androgen Deprivation Therapy (ADT) With LHRH Agonists or Antagonist in Men With Hormone Naive Prostate Cancer

PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.

Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.

Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline

PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline

All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer	NCT03833921	Prostate Cancer... Prostate Cancer	Abiraterone Ace... Prednisone	18 Years -	Baylor College of Medicine
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer	NCT02972060	Prostate Cancer	ODM-201 ADT	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for hormone naive prostate cancer