Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

NCTNCT00924469Other idCR016936Other idCOU-AA-201

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 58 participants (actual)
Sponsor: Janssen Research & Development, LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2009
Primary completion: Feb 2012
Completion: Mar 2012
First posted: 19 Jun 2009 (estimated)
Last update posted: 17 Apr 2013 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 2
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
NCT00924469
Nov 2009 to Mar 2012

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 safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).

Interventions

AbirateroneDrug
LeuprolideDrug
PrednisoneDrug

Arms2

Experimental
Abiraterone plus leuprolide plus prednisone
Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.
Active comparator
Leuprolide then abiraterone plus leuprolide plus prednisone
Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.

Primary outcomes2

Outcomes the sponsor listed as primary.

Testosterone Concentration in Prostate Tissue
Time frame · Week 12
Registry description
Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.
Dihydrotestosterone (DHT) Concentration in Prostate Tissue
Time frame · Week 12
Registry description
The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.

Secondary outcomes(7)

Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue
Time frame · Week 24
Registry description
Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.
Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue
Time frame · Week 12 and 24
Registry description
Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.
Serum Levels of Androgens
Time frame · Week 12 and 24
Registry description
Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.
Percentage of Participants With Prostate-specific Antigen (PSA) Response
Time frame · Weeks 12 and 24
Registry description
The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.
Percentage of Participants With Pathologic Complete Response (CR)
Time frame · Week 24
Registry description
Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.
Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24
Time frame · Week 24
Registry description
Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.
Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment
Time frame · Week 24
Registry description
Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.

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 outcomeMean· Week 12

Testosterone Concentration in Prostate Tissue

Group	Value (Picogram per milligram (pg/mg))	Spread
Abiraterone Plus Leuprolide Plus Prednisone	0.089	0.0637
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	0.228	0.3788

Secondary and other outcome results(7)

Secondary outcomeMean· Week 24

Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue

Group	Value (Picogram per milligram (pg/mg))	Spread
Abiraterone Plus Leuprolide Plus Prednisone	0.216	0.6707
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	0.062	0.0340

Secondary outcomeMean· Week 12 and 24

Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue

Group	Value (Picogram per milligram (pg/mg))	Spread
Abiraterone Plus Leuprolide Plus Prednisone	0.082	0.0525
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	0.277	0.1729

Secondary outcomeMean· Week 12 and 24

Serum Levels of Androgens

Group	Value (Nanogram per deciliter (ng/dL))	Spread
Abiraterone Plus Leuprolide Plus Prednisone	1.049	1.0374
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	10.014	12.5981

Secondary outcomeNumber· Weeks 12 and 24

Percentage of Participants With Prostate-specific Antigen (PSA) Response

Group	Value (Percentage of participants)	Spread
Abiraterone Plus Leuprolide Plus Prednisone	86.7	0.0637
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	3.6	0.3788

Secondary outcomeNumber· Week 24

Percentage of Participants With Pathologic Complete Response (CR)

Group	Value (Percentage of participants)	Spread
Abiraterone Plus Leuprolide Plus Prednisone	10.3	0.0637
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	3.7	0.3788

Secondary outcome· Week 24

Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24

Group	Value
Abiraterone Plus Leuprolide Plus Prednisone	not posted
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	not posted

Secondary outcome· Week 24

Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment

Group	Value
Abiraterone Plus Leuprolide Plus Prednisone	not posted
Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Abiraterone Plus Leuprolide Plus PrednisoneAbiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.	–	6 / 30	30 / 30
Leuprolide Then Abiraterone Plus Leuprolide Plus PrednisoneLeuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.	–	7 / 28	28 / 28

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 * At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements * At least one of the following features: prostate specific antigen (PSA) greater than (\>) 10 nanogram per milliliter (ng/ml); PSA velocity \>2 ng/ml per /year (defined as a rise in PSA of \>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\>=) 7 (4+3); Gleason score 6 if either PSA \>=10 ng/ml or PSA velocity \>=2 ng/ml/year * Serum testosterone \>200 nanogram/deciliter * Participant and urologist must agree that participant is suitable for prostatectomy Exclusion Criteria: * Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection * Abnormal liver function consisting of any of the following: serum bilirubin \>= 1.5 \* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \>=2.5 \* ULN * Uncontrolled hypertension within the Screening period (systolic blood pressure \>= 160 millimeter of mercury \[mmHg\] or diastolic BP \>= 95 mmHg) * Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily * Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction

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