Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT04267887
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Castration-Sensitive Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    Given PO
  • Antiandrogen Therapy — DRUG
    Given ADT per standard of care
  • Apalutamide — DRUG
    Given PO
  • Prednisone — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.

Key Dates

Start date
May 11, 2020
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2030

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (apalutamide, abiraterone acetate, prednisone, ADT)
    Patients receive apalutamide PO QD, abiraterone acetate PO QD, and prednisone PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive androgen deprivation therapy per standard of care. Patients undergo CT scan, bone scan and blood sample collection throughout the study.

Primary Outcome Measure

Complete prostate specific antigen (PSA) response [ Time Frame: At 12 months from the start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By research site
OHSU Knight Cancer Institute· Portland, OR

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