Metastatic CancerPhase 2NCT05422911
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
A Phase 2 study testing Abiraterone acetate, Apalutamide and Enzalutamide in people with Metastatic Cancer and Neoplasm, Prostate, run by Sun Pharmaceutical Industries Limited at 12 sites in United States.
Trial summary
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive
- What is being tested?
- Abiraterone acetate, Apalutamide and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 12 sitesUnited States
- Study dates
- 31 Aug 2022to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans must meet the following to be eligible to participate:
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
- Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
- Have previously begun within 120 days of randomization or will receive androgen-deprivation therapy with a gonadotropin releasing hormone agonist or antagonist or have undergone bilateral orchiectomy (i.e., medical, or surgical castration).
Show all 11Show fewer
- Laboratory tests meet minimum safety requirements:
- Hepatic: AST ≤2.5 X institutional ULN, ALT ≤2.5 X institutional ULN, Total bilirubin ≤1.5X upper limit of normal (ULN) [except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10X ULN].
- Renal: Creatinine clearance ≥30 ml/min or serum creatinine ≤1.8 mg/dl
- Hematological: Platelet count ≥100,000/mm^3; Hemoglobin >9 g/dL; ANC >1 X10^9/L
- Serum potassium >3 mEq/L
Who cannot join
- Subjects with any of the following will not be enrolled:
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
- Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- Patients who are receiving any other investigational agents concurrently.
- Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
- Child-Pugh Class B and C
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105
Phoebe A Tsao, MD, Phoebe.Tsao@va.gov
Laura A Randolph, Laura.Randolph@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Dr. Aihua E. Yen, MD, Aihua.yen@va.gov
Shannie S Oben, Shannie.oben@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Matthew B Rettig, MD, Matthew.Rettig@va.gov
Samantha M Tran, Samantha.Tran@va.gov
- Recruiting
VA New York Harbor Healthcare System
New York, New York, 10010
Victor Adorno Febles, MD, Victor.AdornoFebles@va.gov
Sarah K Loh, Sarah.Loh2@va.gov
- Recruiting
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
Yu-Ning Wong, MD, MSCE, Yu-Ning.Wong@va.gov
Shraddha Patel, Shraddha.Patel2@va.gov
- Recruiting
VA Portland Health Care System
Portland, Oregon, 97239
Julie Graff, MD, Julie.Graff@va.gov
Abigail K Prager, Abigail.Prager@va.gov
- Recruiting
W.G. Bill Hefner Medical Center
Salisbury, North Carolina, 28144
Michael M Goodman, MD, Michael.Goodman2@va.gov
Hillary N Vanskiver, hillary.vanskiver@va.gov
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Robert B Montgomery, MD, Robert.Montgomery@va.gov
Kara Flaherty, Kara.Flaherty@va.gov
- Recruiting
VA St. Louis Health Care System
St Louis, Missouri, 63106
Eric M Knoche, MD, Eric.Knoche@va.gov
Carley Browning, Carley.Browning@va.gov
- Recruiting
James A. Haley Veterans Administration Hospital
Tampa, Florida, 33612
Terrence Grady, D.O., Ph.D., terrence.grady@va.gov
Lisa A Braun, Lisa.Braun2@va.gov
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Tito Fojo, MD, PhD, 718-584-9000 ext. 6120, antonio.fojo@va.gov
Francesca Smith, Francesca.Smith@va.gov
- Recruiting
VA Hudson Valley Health Care System
Wappingers Falls, New York, 12590
Ponciano L Reyes, MD, ponciano.reyes@va.gov
Christina M. Sportiello, Christina.Sportiello@va.gov
About this study
Official title: A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.
But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.
- Conditions
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
- Being tested
- Abiraterone acetate, Apalutamide, Enzalutamide
- Keywords
- YONSA, zytiga, enzalutamide, apalutamide, growth rate, doubling time
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetateDrug
Also called YONSA®, ZYTIGA®, generic ZYTIGA
YONSA® (fine particle formulation abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. Note that in the first four months the YONSA® dose should not exceed 500 mg administered orally once daily.
ZYTIGA® (abiraterone acetate) or generic ZYTIGA 1000 mg (four 250 mg uncoated tablets or two 500 mg film-coasted tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].
ApalutamideDrug
Also called ERLEADA®
Apalutamide (ERLEADA®), 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].
EnzalutamideDrug
Also called XTANDI®
Enzalutamide (XTANDI®), 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy].
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate | Active comparator | Not described Receives: Drug: Abiraterone acetate |
| Standard of Care | Active comparator | Not described Receives: Drug: Apalutamide; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor growth rate (g)
Tumor growth rate (g)
Measured: 2 years
Testosterone levels
Testosterone levels to assess testosterone suppression with androgen deprivation therapy (ADT).
Measured: 2 years
Secondary outcomes (1)
PSA Response
PSA response based Prostate Cancer Working Group 2 guidelines.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators have used clinical trial data and real-world data including national VHA data to successfully demonstrate how even in the real-world, estimated growth rate (g) values accurately predict OS. This study will test the growth rate (g) endpoint prospectively.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Puget Sound Health Care System, VA Greater Los Angeles Healthcare System, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, VA Ann Arbor Healthcare System, Corporal Michael J. Crescenz VA Medical Center, W.G. Bill Hefner Medical Center, Portland VA Medical Center, Michael E. DeBakey VA Medical Center, VA St. Louis Health Care System, VA Hudson Valley HealthCare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422911
- Sponsor's protocol ID
- 1641701
- Other IDs
- 21-35
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study of Abiraterone Acetate, Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT05422911
- Acronym / sponsor ID
- 1641701
- Conditions
- Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive, Castrate-sensitive Prostate Cancer
- Keywords
- YONSA, zytiga, enzalutamide, apalutamide, growth rate, doubling time
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Collaborators
- VA Puget Sound Health Care System, VA Greater Los Angeles Healthcare System, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System, VA Ann Arbor Healthcare System, Corporal Michael J. Crescenz VA Medical Center, W.G. Bill Hefner Medical Center, Portland VA Medical Center, Michael E. DeBakey VA Medical Center, VA St. Louis Health Care System, VA Hudson Valley HealthCare System
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively.
But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators have used clinical trial data and real-world data including national VHA data to successfully demonstrate how even in the real-world, estimated growth rate (g) values accurately predict OS. This study will test the growth rate (g) endpoint prospectively.
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate | Active comparator | Drug: Abiraterone acetate |
| Standard of Care | Active comparator | Drug: Apalutamide, Drug: Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Veterans must meet the following to be eligible to participate:
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (on a scale from 0 to 5, with higher scores indicating greater disability and a score of 5 indicating death).
- Histologically or cytologically confirmed adenocarcinoma of the prostate without morphologic evidence of small-cell features in either a recently obtained sample or in the archival sample at the time of diagnosis.
Key exclusion criteria (7 listed)
- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, apalutamide or enzalutamide or darolutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo).
- Treatment with hormonal therapy (e.g., androgen receptor inhibitors other than bicalutamide, estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist therapy) within 4 weeks of randomization.
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
- Patients who are receiving any other investigational agents concurrently.
- Clinically significant heart disease as evidenced by New York Heart Association (NYHA) Class III-IV heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone acetateAlso: YONSA®, ZYTIGA®, generic ZYTIGAYONSA® (fine particle formulation abiraterone acetate), YONSA® 500 mg (four 125 mg tablets) or 625 mg (five 125 mg tablets) administered orally once daily in combination with methylprednisolone 4 mg administered orally twice daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. Note that in the first four months the YONSA® dose should not exceed 500 mg administered orally once daily. ZYTIGA® (abiraterone acetate) or generic ZYTIGA 1000 mg (four 250 mg uncoated tablets or two 500 mg film-coasted tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. | Drug | Abiraterone Acetate |
| ApalutamideAlso: ERLEADA®Apalutamide (ERLEADA®), 240 mg (four 60 mg tablets) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. | Drug | Standard of Care |
| EnzalutamideAlso: XTANDI®Enzalutamide (XTANDI®), 160 mg (four 40 mg capsules) administered orally once daily + physician's choice GnRH agonist/antagonist [unless the Veteran has had prior bilateral orchiectomy]. | Drug | Standard of Care |
Primary outcome
Tumor growth rate (g)
Time frame: 2 years
Tumor growth rate (g)
Testosterone levels
Time frame: 2 years
Testosterone levels to assess testosterone suppression with androgen deprivation therapy (ADT).
1 secondary outcome
PSA Response
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone acetate, Apalutamide and Enzalutamide in people with Metastatic Cancer and Neoplasm, Prostate, run by Sun Pharmaceutical Industries Limited at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tito Fojo, MD, PhD (718-584-9000 ext. 6120, antonio.fojo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor growth rate (g) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.