Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02217566
• Date of registration: 13/08/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
• Scientific title: Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
• Date of first enrolment: September 23, 2014
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02217566
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil, Colombia

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

- Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer.
Participants should demonstrate evidence of progression on DES or evidence of grades
3/4 toxicities on DES

- Metastatic disease documented by positive bone scan or metastatic lesions on
computerized tomography (CT) or magnetic resonance imaging (MRI)

- May have received prior androgen blockage (bicalutamide or flutamide) but must have
been discontinued for least 28 days

- Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone
[LHRH] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram
per deciliter (1.7 nanomole per liter) and eligible participants must maintain ADT

Exclusion Criteria:

- Active infection or other medical condition that would make prednisone use
contraindicated

- Any chronic medical condition requiring a higher systemic dose of corticosteroid than
5 milligram (mg) prednisone per day

- Pathological finding consistent with small cell carcinoma of the prostate

- Known brain metastasis

- Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of
metastatic castration-resistant prostate cancer (mCRPC)



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Drug: Androgen deprivation therapy (ADT)

Drug: Prednisone

Drug: Abiraterone acetate

Primary Outcome(s)

Time to Prostate-specific Antigen (PSA) Progression [Time Frame: Up to 2 years]

Secondary Outcome(s)

Overall Survival [Time Frame: Up to 4 years]

Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score [Time Frame: Up to 2 years]

Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response [Time Frame: Week 12 to any time up to 2 years]

Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score [Time Frame: Up to 2 years]

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to 4 years]

Secondary ID(s)

CR103352

212082PCR2036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02217566