Advanced Prostate AdenocarcinomaPhase 2NCT06173362
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
A Phase 2 study testing Abiraterone, Biospecimen Collection and Darolutamide in people with Advanced Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, run by University of California, Davis at 1 site in United States.
Trial summary
This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- What is being tested?
- Abiraterone, Biospecimen Collection and Darolutamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to May 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
- Ability to understand and willingness to sign an informed consent form
- Histologically confirmed prostate adenocarcinoma
- Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
- Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
- Performance status 0 - 2 (Karnofsky ≥ 50%)
- Age ≥ 18 years at time of consent
- Life expectancy ≥ 6 months per investigator discretion
- Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study
Who cannot join
- Have been on either abiraterone or darolutamide for > 28 days prior to initiating enrollment
- Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Mamta Parikh
About this study
Official title: A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide
This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Tolerability.
SECONDARY OBJECTIVES:
- Tolerability in prespecified subpopulations.
II. Prostate-specific antigen (PSA) response at 7 months.
OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference.
ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.
ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.
After completion of study intervention, patients are followed up for a total of 3 years.
- Conditions
- Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Being tested
- Abiraterone, Biospecimen Collection, Darolutamide, Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Also called CB 7598
Given abiraterone
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
DarolutamideDrug
Also called Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788
Given darolutamide
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given prednisone
| Study group | Role | What they receive |
|---|---|---|
| Arm I (abiraterone, prednisone) | Experimental | Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. Receives: Drug: Abiraterone; Procedure: Biospecimen Collection; Drug: Prednisone |
| Arm II (darolutamide) | Experimental | Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. Receives: Procedure: Biospecimen Collection; Drug: Darolutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3 or higher adverse events
Will be defined and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start9 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mamta Parikh, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173362
- Sponsor's protocol ID
- UCDCC315
- Other IDs
- NCI-2023-09814, UCDCC315, P30CA093373
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Phase II Study Evaluating Tolerability in Prostate Cancer Patients Treated With Abiraterone + Prednisone or Darolutamide
- ClinicalTrials.gov ID
- NCT06173362
- Acronym / sponsor ID
- UCDCC315
- Conditions
- Advanced Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Dec 2023 (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.
This phase II trial compares the effects, good and/or bad of abiraterone and prednisone or darolutamide alone in treating patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Androgens (male hormones) can cause the growth of prostate tumor cells. Abiraterone acetate lowers the amount of androgens made by the body. This may help stop the growth of prostate tumor cells that need androgen to grow. Darolutamide blocks the use of androgens by the tumor cells. Prednisone is used to lessen inflammation and lower the body's immune response. Researchers want to compare the side effects of standard of care (SOC) abiraterone and prednisone or darolutamide alone in treating patients with advanced prostate cancer.
Detailed description
PRIMARY OBJECTIVE:
- Tolerability.
SECONDARY OBJECTIVES:
- Tolerability in prespecified subpopulations.
II. Prostate-specific antigen (PSA) response at 7 months.
OUTLINE: Patients are assigned to 1 of 2 arms per treating physician preference.
ARM I: Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.
ARM II: Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.
After completion of study intervention, patients are followed up for a total of 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (abiraterone, prednisone) | Experimental | Drug: Abiraterone, Procedure: Biospecimen Collection, Drug: PrednisonePatients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. |
| Arm II (darolutamide) | Experimental | Procedure: Biospecimen Collection, Drug: DarolutamidePatients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and willingness to sign an informed consent form
- Histologically confirmed prostate adenocarcinoma
- Advanced prostate cancer appropriate for treatment with abiraterone acetate plus prednisone or darolutamide as assessed by the treating physician
- Participants are encouraged to be currently treated with androgen deprivation therapy (ADT) or having undergone bilateral orchiectomy
- Performance status 0 - 2 (Karnofsky ≥ 50%)
Key exclusion criteria (2 listed)
- Have been on either abiraterone or darolutamide for > 28 days prior to initiating enrollment
- Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial
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 |
|---|---|---|
| AbirateroneAlso: CB 7598Given abiraterone | Drug | Arm I (abiraterone, prednisone) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Arm I (abiraterone, prednisone), Arm II (darolutamide) |
| DarolutamideAlso: Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788Given darolutamide | Drug | Arm II (darolutamide) |
| PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven prednisone | Drug | Arm I (abiraterone, prednisone) |
Primary outcome
Incidence of grade 3 or higher adverse events
Time frame: At 12 months
Will be defined and graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).
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 13 Mar 2026.
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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.
Mamta Parikh principal investigator
University of California, Davis
1 site 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, Biospecimen Collection and Darolutamide in people with Advanced Prostate Adenocarcinoma and Stage III Prostate Cancer AJCC v8, run by University of California, Davis at 1 site 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 8 inclusion and 2 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 OCR Referral Team (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3 or higher adverse events (time frame: At 12 months). 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 13 Mar 2026.