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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02217566 (opens ClinicalTrials.gov in a new tab)Other idCR103352Other id212082PCR2036
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the description.
  • Names Leuprolide, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
46 participants (actual)
Sponsor
Janssen Research & Development, LLC · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Brazil

Start
23 Sept 2014
Primary completion
26 Oct 2018
Completion
26 Oct 2018
First posted
15 Aug 2014 (estimated)
Last update posted
13 Jan 2020
Conditions
Prostatic Neoplasms

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 2

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

    NCT02217566

    23 Sept 2014 to 26 Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).

Interventions

  • Abiraterone acetateDrug
  • PrednisoneDrug
  • Androgen deprivation therapy (ADT)Drug

Arms1

  • Experimental

    Abiraterone Acetate

    Participants will receive abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Prostate-specific Antigen (PSA) Progression

    Time frame · Up to 2 years

    Registry description

    Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (\>=) 25 percent (%) and \>=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is \>=25% and \>=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline).

Secondary outcomes(5)

  1. Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response

    Time frame · Week 12 to any time up to 2 years

    Registry description

    The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline.

  2. Overall Survival

    Time frame · Up to 4 years

    Registry description

    Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive.

  3. 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

    Registry description

    The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.

  4. 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

    Registry description

    The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use.

  5. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame · Up to 4 years

    Registry description

    An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 2 years

Time to Prostate-specific Antigen (PSA) Progression

GroupValue (Months)
Abiraterone Acetate7.3
Secondary and other outcome results(5)
Secondary outcomeNumber· Week 12 to any time up to 2 years

Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response

GroupValue (Percentage of participants)
Abiraterone Acetate57.50
Secondary outcomeMedian· Up to 4 years

Overall Survival

GroupValue (Months)
Abiraterone Acetate29.6
Secondary outcomeNumber· Up to 2 years

Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score

GroupValue (Percentage of participants)
Abiraterone Acetate19.44
Secondary outcomeNumber· Up to 2 years

Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score

GroupValue (Percentage of participants)
Abiraterone Acetate15.15
Secondary outcomeCount of participants· Up to 4 years

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

GroupValue (Participants)
Abiraterone Acetate45

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Abiraterone AcetateParticipants received abiraterone acetate 1000 milligram (mg) orally once daily along with prednisone 5 mg orally once daily and androgen deprivation therapy (ADT) as per Investigator's discretion until prostate-specific Antigen (PSA) progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.3 / 4611 / 4645 / 46

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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