Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Cortisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Participants receive abiraterone acetate PO once daily QD, apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Apalutamide

Bagi Jana, MD

This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

PRIMARY OBJECTIVE:

I. To assess the radiographic progression free survival (PFS) of men with metastatic castration resistant prostate cancer (mCRPC) who are selected for treatment based on positive biomarker signature.

SECONDARY OBJECTIVES:

I. Safety. II. Composite progression free survival (PFSc) defined by Prostate Cancer Working Group 2 (PCWG2) (radiographic progression, prostate specific antigen \[PSA\] progression, or clinical deterioration).

III. Overall survival. IV. Exploratory biomarker analyses. V. Measures of prostate specific antigen (PSA) decline and associations with outcome.

VI. Radiologic response by PCWG2 criteria. VII. Measures of circulating tumor cell (CTC) and conversion to undetectable and/or favorable \< 5.

OUTLINE:

Participants receive abiraterone acetate orally (PO) once daily (QD), apalutamide PO QD, and prednisone PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up for up to 16 months.

Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer

A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature

Will be assessed using primary analysis set (PAS). Kaplan-Meier curves will be presented.

Will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03 with grade and attribution to study drug.

Will be assessed using marker evaluable set (MES). The association between the biomarker and PSA level will be estimated using Spearman's rank correlation.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.

Radical Prostatectomy

Robert Montgomery

This phase II trial studies how well olaparib works in treating participants with prostate cancer that has not spread to other parts of the body (localized). Olaparib may stop the growth of tumor cells by interfering with the activity of a substance called PARP, which is inside cells. Giving olaparib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVE:

I. To assess the pathological complete response rate following olaparib when administered as neoadjuvant therapy prior to prostatectomy in patients with localized prostate cancer containing homozygous or complementary deoxyribonucleic acid \[DNA\] repair deficiency.

SECONDARY OBJECTIVE:

I. To determine the rate of positive surgical margins, extracapsular extension, positive seminal vesicles and lymph nodes at the time of prostatectomy.

OUTLINE:

Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.

After completion of study treatment, participants are followed up for 30 days.

Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer

Open-Label, Pilot Study of Olaparib as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Percent of patients who achieve a pCR at the time of prostatectomy, after 12 weeks of neoadjuvant therapy with olaparib. PCR is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen. Assessment will be based on the recommendations of the International Society of Urological Pathology (ISUP).

Will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).

The rate of detectable tumor in pathology specimens obtained at prostatectomy.

Pathology specimens obtained at prostatectomy will be assessed using the tumor, lymph node, and metastasis (TNM) staging system for prostate cancer.

Stage Stage 2 represents patients with disease without evidence of extension outside of the prostate Stage 3 represents patients with disease which has penetrated the capsule of the prostate

AstraZeneca

University of Washington

Adverse events were collected according to CTCAE version 5

Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.

Olaparib: Given PO

Radical Prostatectomy: Undergo surgery

Treatment (Olaparib, Radical Prostatectomy)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Bruce Montgomery, PI

Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy.

Olaparib: Given PO

Radical Prostatectomy: Undergo surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer	NCT03360721	Castration-Resi... Prostate Adenoc... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Abiraterone Ace... Apalutamide Prednisone	18 Years -	M.D. Anderson Cancer Center
Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer	NCT03570476	Prostate Adenoc... Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost...	Olaparib Radical Prostat...	18 Years -	University of Washington

Spots Global Cancer Trial Database for prostate adenocarcinoma without neuroendocrine differentiation