Trial · NCT01715285
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)
NCT01715285, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2018-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01715285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01715285
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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)
- NCT number
- NCT01715285
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,209 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Prostate Neoplasms
- Interventions
- Abiraterone acetate, Prednisone, Androgen deprivation therapy (ADT), Abiraterone acetate Placebo, Prednisone Placebo
- First posted
- 2012-10-26
- Last updated
- 2025-02-04
- Other registries' IDs
- eudract:2012-002940-26
- Results first posted
- 2018-10-15
- Limitations and caveats
- As per protocol the long-term extension (LTE) phase was planned but LTE phase is not included as part of this study hence no data was reported for LTE phase.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Progression-Free Survival (PFS) | Up to 44 months | Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 \[PCWG2\] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter. |
| Primary | Overall Survival (OS) | Up to 66 months | Overall survival was defined as the time from randomization to date of death from any cause. |
| Secondary | Time to Initiation of Chemotherapy | Up to 66 months | Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. |
| Secondary | Time to Subsequent Therapy for Prostate Cancer | Up to 66 months | Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer. |
| Secondary | Time to Pain Progression | Up to 66 months | Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine. |
| Secondary | Time to Skeletal-Related Event | Up to 66 months | Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone. |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Up to 66 months | Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression-Free Survival (PFS) | Up to 44 months | Intention to treat (ITT) analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Initiation of Chemotherapy | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Subsequent Therapy for Prostate Cancer | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Time to Pain Progression | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
| SECONDARY | Time to Skeletal-Related Event | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | months | MEDIAN |
| SECONDARY | Time to Prostate-Specific Antigen (PSA) Progression | Up to 66 months | ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radiographic Progression-Free Survival (PFS) | Abiraterone Acetate+Prednisone+ADT | 33.02 | 95% Confidence Interval 29.57 to NA | Months | |
| Radiographic Progression-Free Survival (PFS) | Placebo + ADT | 14.78 | 95% Confidence Interval 14.69 to 18.27 | Months | |
| Overall Survival (OS) | Abiraterone Acetate+Prednisone+ADT | 53.32 | 95% Confidence Interval 48.23 to NA | months | |
| Overall Survival (OS) | Placebo + ADT | 36.53 | 95% Confidence Interval 33.54 to 39.95 | months | |
| Time to Initiation of Chemotherapy | Abiraterone Acetate+Prednisone+ADT | NA | 95% Confidence Interval 62.62 to NA | months | |
| Time to Initiation of Chemotherapy | Placebo + ADT | 57.59 | 95% Confidence Interval 38.18 to NA | months | |
| Time to Subsequent Therapy for Prostate Cancer | Abiraterone Acetate+Prednisone+ADT | 54.87 | 95% Confidence Interval 46.42 to NA | Months | |
| Time to Subsequent Therapy for Prostate Cancer | Placebo + ADT | 21.22 | 95% Confidence Interval 18.56 to 23.49 | Months | |
| Time to Pain Progression | Abiraterone Acetate+Prednisone+ADT | 47.41 | 95% Confidence Interval 33.15 to NA | Months | |
| Time to Pain Progression | Placebo + ADT | 16.62 | 95% Confidence Interval 11.07 to 23.95 | Months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Period (Up to 23 Months) | STARTED | Abiraterone Acetate+Prednisone+ADT | 597 | |
| Double Blind Period (Up to 23 Months) | STARTED | Placebo + ADT | 602 | |
| Double Blind Period (Up to 23 Months) | STARTED | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 0 | |
| Double Blind Period (Up to 23 Months) | COMPLETED | Abiraterone Acetate+Prednisone+ADT | 0 | |
| Double Blind Period (Up to 23 Months) | COMPLETED | Placebo + ADT | 0 | |
| Double Blind Period (Up to 23 Months) | COMPLETED | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 0 | |
| Double Blind Period (Up to 23 Months) | NOT COMPLETED | Abiraterone Acetate+Prednisone+ADT | 597 | |
| Double Blind Period (Up to 23 Months) | NOT COMPLETED | Placebo + ADT | 602 | |
| Double Blind Period (Up to 23 Months) | NOT COMPLETED | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 0 | |
| OLE Phase (Up to 15.6 Months) | STARTED | Abiraterone Acetate+Prednisone+ADT | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events831
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Abiraterone Acetate+Prednisone+ADT | 58 | 597 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + ADT | 89 | 602 | |
| other | Anaemia | Blood and lymphatic system disorders | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 3 | 72 | |
| other | Abdominal Pain | Gastrointestinal disorders | Abiraterone Acetate+Prednisone+ADT | 26 | 597 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo + ADT | 31 | 602 | |
| other | Abdominal Pain | Gastrointestinal disorders | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 0 | 72 | |
| other | Constipation | Gastrointestinal disorders | Abiraterone Acetate+Prednisone+ADT | 68 | 597 | |
| other | Constipation | Gastrointestinal disorders | Placebo + ADT | 67 | 602 | |
| other | Constipation | Gastrointestinal disorders | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 2 | 72 | |
| other | Diarrhoea | Gastrointestinal disorders | Abiraterone Acetate+Prednisone+ADT | 37 | 597 |
1 to 10 of 831Source ClinicalTrials.gov
See all 831 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abiraterone Acetate+Prednisone+ADT | 275 | 597 |
| Total, all-cause mortality | Placebo + ADT | 339 | 602 |
| Total, all-cause mortality | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 4 | 72 |
| Total, other adverse events | Abiraterone Acetate+Prednisone+ADT | 533 | 597 |
| Total, other adverse events | Placebo + ADT | 515 | 602 |
| Total, other adverse events | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 35 | 72 |
| Total, serious adverse events | Abiraterone Acetate+Prednisone+ADT | 192 | 597 |
| Total, serious adverse events | Placebo + ADT | 151 | 602 |
| Total, serious adverse events | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 4 | 72 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01715285
GET https://conductscience.org/api/trials/v1/NCT01715285/events?page=2