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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01715285




Registration number
NCT01715285
Ethics application status
Date submitted
24/10/2012
Date registered
26/10/2012
Date last updated
13/03/2023

Titles & IDs
Public title
A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
Scientific title
A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Secondary ID [1] 0 0
212082PCR3011
Secondary ID [2] 0 0
CR100900
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone
Other interventions - Androgen deprivation therapy (ADT)
Treatment: Drugs - Abiraterone acetate Placebo
Treatment: Drugs - Prednisone Placebo

Experimental: Abiraterone acetate + Prednisone + ADT - Participants will receive abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) will be administered.

Placebo Comparator: Placebo + Androgen Deprivation Therapy (ADT) - Participants will receive placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT will be administered.


Treatment: Drugs: Abiraterone acetate
Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Prednisone
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Other interventions: Androgen deprivation therapy (ADT)
All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Abiraterone acetate Placebo
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

Treatment: Drugs: Prednisone Placebo
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 44 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [1] 0 0
Time to Initiation of Chemotherapy
Timepoint [1] 0 0
Up to 66 months
Secondary outcome [2] 0 0
Time to Subsequent Therapy for Prostate Cancer
Timepoint [2] 0 0
Up to 66 months
Secondary outcome [3] 0 0
Time to Pain Progression
Timepoint [3] 0 0
Up to 66 months
Secondary outcome [4] 0 0
Time to Skeletal-Related Event
Timepoint [4] 0 0
Up to 66 months
Secondary outcome [5] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [5] 0 0
Up to 66 months

Eligibility
Key inclusion criteria
- Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with
histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell histology

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

- At least 2 of the following high-risk prognostic factors: Gleason score of greater
than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of
measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response
Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2

- Adequate hematologic, hepatic, and renal function

- Agrees to protocol-defined use of effective contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 mg prednisone per day

- Pathological finding consistent with small cell carcinoma of the prostate

- Known brain metastasis

- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate
cancer (the following exception are permitted): up to 3 months of androgen deprivation
therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or
orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1;
participants may have one course of palliative radiation or surgical therapy to treat
symptoms resulting from metastatic disease if it was administered at least 28 days
prior to Cycle 1 Day 1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2022
Sample size
Target
Accrual to date
Final
1209
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Footscray
Recruitment hospital [3] 0 0
- Liverpool
Recruitment hospital [4] 0 0
- Malvern
Recruitment hospital [5] 0 0
- Randwick
Recruitment hospital [6] 0 0
- Wahroonga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Footscray
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- Wahroonga
Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Charleroi
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Liège
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Sao Paulo
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Bulgaria
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Gabrovo
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Sofia
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Alberta
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Manitoba
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Dnepropetrovsk
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Dnipro
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Lviv
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Makiivka
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Ukraine
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Odessa
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Ukraine
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Uzhgorod
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Ukraine
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Zaporizhzhia
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Glasgow
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Nottingham
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Oxford
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United Kingdom
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if newly diagnosed (within previous 3 months)
participants with metastatic (spread of cancer cells from one part of the body to another )
hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from
the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy
(ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01715285
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries