A Phase 3 interventional study of Abiraterone acetate and Prednisone in Prostate Neoplasms, sponsored by Janssen Research & Development, LLC. Completed at 208 sites in 33 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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).
This is a randomized (the treatment group is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study designed to determine the efficacy of abiraterone acetate plus low-dose prednisone in participants with mHNPC. The study consists of 4 parts: Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as 1,000 milligram [mg] plus 5 mg prednisone or only placebo orally); Follow-up Phase (every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or study termination) Open-label Extension (OLE) Phase. Participants in the Double-blind Treatment Phase will have the opportunity to enroll into the OLE Phase. The OLE Phase will allow participants to receive active drug (abiraterone acetate plus prednisone) until Long-term Extension (LTE) Phase for an additional period of up to 3 years. Participants will discontinue study treatment at disease progression or unacceptable toxicity unless, in the Investigator's opinion, it is deemed that the participants will continue to derive benefit from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and radiographic progression-free survival. Participants' safety will be monitored throughout the study.
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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.
Drug: Abiraterone acetate · Drug: Prednisone · Other: 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.
Other: Androgen deprivation therapy (ADT) · Drug: Abiraterone acetate Placebo · Drug: Prednisone Placebo
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.
Also known as: Zytiga
Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
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.
Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Radiographic Progression-Free Survival (PFS)
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.
Time frame: Up to 44 months
Overall Survival (OS)
Overall survival was defined as the time from randomization to date of death from any cause.
Time frame: Up to 66 months
Time to Initiation of Chemotherapy
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.
Time frame: Up to 66 months
Time to Subsequent Therapy for Prostate Cancer
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.
Time frame: Up to 66 months
Time to Pain Progression
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.
Time frame: Up to 66 months
Time to Skeletal-Related Event
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.
Time frame: Up to 66 months
Time to Prostate-Specific Antigen (PSA) Progression
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.
Time frame: Up to 66 months
| Milestone | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate |
|---|---|---|---|
| Started | 597 | 602 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 597 | 602 | 0 |
| Withdrew: Adverse event | 53 | 31 | 0 |
| Withdrew: Death | 43 | 25 | 0 |
| Withdrew: Lost to follow-up | 3 | 2 | 0 |
| Withdrew: Physician decision | 21 | 23 | 0 |
| Withdrew: Withdrawal by subject | 52 | 47 | 0 |
| Withdrew: Progressive disease | 254 | 388 | 0 |
| Withdrew: Noncompliance with study drug | 4 | 2 | 0 |
| Withdrew: Placebo cross-over | 0 | 72 | 0 |
| Withdrew: Other | 167 | 12 | 0 |
| Milestone | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate |
|---|---|---|---|
| Started | 0 | 0 | 72 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 72 |
| Withdrew: Death | 0 | 0 | 4 |
| Withdrew: Other | 0 | 0 | 60 |
| Withdrew: Progressive disease | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 6 |
| Withdrew: Adverse event | 0 | 0 | 1 |
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.
| Months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Radiographic Progression-Free Survival (PFS) | 33.02 (29.57 to NA) | 14.78 (14.69 to 18.27) |
Overall survival was defined as the time from randomization to date of death from any cause.
| months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Overall Survival (OS) | 53.32 (48.23 to NA) | 36.53 (33.54 to 39.95) |
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.
| months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Time to Initiation of Chemotherapy | NA (62.62 to NA) | 57.59 (38.18 to NA) |
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.
| Months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Time to Subsequent Therapy for Prostate Cancer | 54.87 (46.42 to NA) | 21.22 (18.56 to 23.49) |
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.
| Months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Time to Pain Progression | 47.41 (33.15 to NA) | 16.62 (11.07 to 23.95) |
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.
| months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Time to Skeletal-Related Event | NA (NA to NA) | NA (NA to NA) |
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.
| Months | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT |
|---|---|---|
| Time to Prostate-Specific Antigen (PSA) Progression | 33.31 (29.44 to 46.09) | 7.43 (7.20 to 9.20) |
Collected over From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abiraterone Acetate+Prednisone+ADT | 275/597 (46.1%) | 192/597 (32.2%) | 533/597 (89.3%) |
| Placebo + ADT | 339/602 (56.3%) | 151/602 (25.1%) | 515/602 (85.5%) |
| DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate | 4/72 (5.6%) | 4/72 (5.6%) | 35/72 (48.6%) |
| Event | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate |
|---|---|---|---|
| PneumoniaInfections and infestations | 12/597 | 2/602 | 0/72 |
| Spinal Cord CompressionNervous system disorders | 11/597 | 11/602 | 0/72 |
| Urinary RetentionRenal and urinary disorders | 10/597 | 11/602 | 0/72 |
| Back PainMusculoskeletal and connective tissue disorders | 5/597 | 10/602 | 0/72 |
| AnaemiaBlood and lymphatic system disorders | 6/597 | 6/602 | 1/72 |
| GastritisGastrointestinal disorders | 0/597 | 0/602 | 1/72 |
| Osteomyelitis AcuteInfections and infestations | 0/597 | 0/602 | 1/72 |
| Diabetes MellitusMetabolism and nutrition disorders | 0/597 | 1/602 | 1/72 |
| Urinary Tract InfectionInfections and infestations | 8/597 | 5/602 | 0/72 |
| Bone PainMusculoskeletal and connective tissue disorders | 8/597 | 6/602 | 0/72 |
| Event | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate |
|---|---|---|---|
| HypertensionVascular disorders | 229/597 | 133/602 | 4/72 |
| HypokalaemiaMetabolism and nutrition disorders | 143/597 | 23/602 | 9/72 |
| Back PainMusculoskeletal and connective tissue disorders | 120/597 | 122/602 | 5/72 |
| Alanine Aminotransferase IncreasedInvestigations | 100/597 | 77/602 | 5/72 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 96/597 | 86/602 | 4/72 |
| Hot FlushVascular disorders | 92/597 | 76/602 | 1/72 |
| Aspartate Aminotransferase IncreasedInvestigations | 91/597 | 68/602 | 5/72 |
| FatigueGeneral disorders | 84/597 | 90/602 | 1/72 |
| Bone PainMusculoskeletal and connective tissue disorders | 81/597 | 90/602 | 0/72 |
| AnaemiaBlood and lymphatic system disorders | 58/597 | 89/602 | 3/72 |
Intent-to-Treat (ITT) analysis set included all participants randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received. .
| Age, Categorical(Participants) | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | Total |
|---|---|---|---|
| <=18 years — <=18 years | 0 | 0 | 0 |
| <=18 years — Between 18 and 65 years | 221 | 233 | 454 |
| <=18 years — >=65 years | 376 | 369 | 745 |
| Age, Continuous(years) | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | Total |
|---|---|---|---|
| Mean | 67.3 ± 8.48 | 66.8 ± 8.72 | 67.1 ± 8.6 |
| Sex: Female, Male(Participants) | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 597 | 602 | 1199 |
| Region of Enrollment(Participants) | Abiraterone Acetate+Prednisone+ADT | Placebo + ADT | Total |
|---|---|---|---|
| Argentina | 8 | 8 | 16 |
| Australia | 4 | 4 | 8 |
| Belgium | 6 | 7 | 13 |
| Brazil | 28 | 28 | 56 |
| Bulgaria | 1 | 1 | 2 |
| Canada | 16 | 17 | 33 |
| Chile | 3 | 4 | 7 |
| China | 69 | 68 | 137 |
| Colombia | 10 | 7 | 17 |
| Czech Republic | 9 | 7 | 16 |
| Denmark | 13 | 15 | 28 |
| Finland | 4 | 5 | 9 |
| France | 7 | 7 | 14 |
| Germany | 4 | 4 | 8 |
| Hungary | 17 | 17 | 34 |
| Israel | 14 | 16 | 30 |
| Italy | 19 | 20 | 39 |
| Japan | 35 | 35 | 70 |
| Malaysia | 4 | 2 | 6 |
| Mexico | 19 | 19 | 38 |
| Netherlands | 6 | 4 | 10 |
| New Zeland | 6 | 5 | 11 |
| Poland | 20 | 22 | 42 |
| Portugal | 19 | 20 | 39 |
| Romania | 22 | 21 | 43 |
| Russian Federation | 89 | 95 | 184 |
| Slovakia | 17 | 14 | 31 |
| South Africa | 10 | 10 | 20 |
| South Korea | 16 | 16 | 32 |
| Spain | 16 | 17 | 33 |
| Sweden | 11 | 11 | 22 |
| Turkey | 18 | 17 | 35 |
| Ukraine | 39 | 40 | 79 |
| United Kingdom | 18 | 19 | 37 |
Showing the first 100 of 208 sites across 33 countries.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Abiraterone Acetate · Prednisone
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