AzTrials
AzTrials

Metastatic Castration-Resistant Prostate AdenocarcinomaPhase 2/3NCT07852195

Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate Cancer

A Phase 2/3 study testing Abiraterone Acetate, Biospecimen Collection and Bone Scan in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

This phase II/II trial compares the effect of high dose testosterone followed by darolutamide with the usual care in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and keeps growing even when the amount of testosterone in the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abiraterone Acetate, Biospecimen Collection and Bone Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
No sites listed yet
Study dates
6 Jan 2027to 31 Mar 2030
Phase
Phase 2/3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be ≥ 18 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • Patient must have documented histologically confirmed adenocarcinoma of the prostate
  • Patient must have evidence of metastatic castration resistant prostate cancer (mCRPC) defined by Prostate Cancer Working Group 3 criteria as follows:
  • Prostate-specific antigen (PSA) progression defined as PSA ≥ 2 ng/mL and rising on two successive measurements at least 14 days apart (most recent PSA value must be within 28 days prior to randomization) AND
  • Castrate serum testosterone level ≤ 50 ng/dL
Show all 36Show fewer
  • Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g., "burst", which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal, intra-articular and/or topical steroids are eligible
  • Patients must have progressed on prior androgen receptor pathway inhibitors (ARPI) including, but not limited to, abiraterone, enzalutamide, apalutamide, or darolutamide. There must be at least a 2-week washout period after stopping ARPI prior to randomization
  • NOTE: Prior bicalutamide is allowed and does not count as an ARPI
  • Patient must not have prior chemotherapy for the treatment of mCRPC. Patient may have received docetaxel for the treatment of hormone-sensitive prostate cancer
  • NOTE: This includes high dose testosterone therapy for prostate cancer
  • Patient must have at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, MRI and/or bone scan and is suitable for repeated assessment. Baseline imaging must be obtained within 28 days prior to randomization
  • Patient must not have current cancer-related pain requiring the use of opiates at the time of randomization
  • Patient must not have received any systemic therapy or radiotherapy within 14 days prior to randomization
  • NOTE: Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is allowed
  • Patient must not have evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (i.e., femoral metastases with concern over fracture risk, spinal or epidural metastases with concern over spinal cord compression)
  • Patient must not have tumor causing urinary outlet obstruction that requires self-catheterization for voiding. Patients with indwelling catheter (e.g., foley or suprapubic catheter) for urinary obstruction are eligible. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes are eligible
  • Patient must not have prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to randomization unless they are receiving therapeutic anticoagulation
  • Patient must not expect to father children by using accepted and effective method(s) of contraception or by abstaining from heterosexual intercourse for the duration of their participation in this study treatment and for four months after the last dose of Arm A protocol treatment and for 3 months after the last dose of Arm B protocol treatment
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Hemoglobin (Hgb) > 7 g/dL and < 17 g/dL (obtained ≤ 14 days prior to protocol randomization)
  • Leukocytes ≥ 3,000/mm^3 (obtained ≤ 14 days prior to protocol randomization)
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3 (obtained ≤ 14 days prior to protocol randomization)
  • Platelets ≥ 100,000/mm^3 (obtained ≤ 14 days prior to protocol randomization)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 × institutional ULN (obtained ≤ 14 days prior to protocol randomization)
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 (obtained ≤ 14 days prior to protocol randomization)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better
  • Patient must be English or Spanish speaking to be eligible for the QOL component of the study
  • NOTE: Sites cannot translate the associated QOL forms

Who cannot join

None listed.

About this study

Official title: A Randomized Phase II/III Trial Evaluating Bipolar Androgen Therapy Followed by Darolutamide vs. Standard of Care in Patients With Metastatic Castration Resistant Prostate Cancer

This phase II/II trial compares the effect of high dose testosterone followed by darolutamide with the usual care in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant). Usual care treatment for patients with metastatic prostate cancer includes surgery or medical castration which involves drugs to suppress the function of the testes. After receiving this therapy, a period of disease stability occurs, followed typically by cancer regrowth and castration-resistant disease. Castration-resistant prostate cancer occurs because the tumor cells are eventually able to adapt to the very low levels of testosterone in the body. A new type of therapy called Bipolar Androgen Therapy (BAT) involves giving patients very high doses of testosterone every 28 days. This results in a cycle of higher than normal testosterone levels (i.e., "supraphysiologic") to near castrate levels over the 28 days. BAT may be able to stop prostate tumor cells from becoming castrate-resistant. In this trial, patients who receive BAT with high dose testosterone and experience disease progression then receive darolutamide. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Adding BAT with high dose testosterone prior to darolutamide after disease progression may help shrink or stabilize metastatic castration-resistant prostate cancer better than usual treatments alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate if BAT followed by darolutamide (Arm B) is associated with improved second progression-free survival (PFS2) post second treatment compared to physician's choice standard of care (SOC)1 followed by SOC2 (Arm A) in men with mCRPC who have progressed on prior androgen receptor pathway inhibitor (ARPI). (Phase II) II. To evaluate if BAT followed by darolutamide (Arm B) is associated with improved overall survival (OS) compared to physician's choice SOC1 followed by SOC2 (Arm A) in men with mCRPC who have progressed on prior ARPI. (Phase III) III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between Arms A and B. (Quality of Life [QOL] objective)

SECONDARY OBJECTIVES:

  1. To evaluate the radiographic progression-free survival (PFS) following initial randomization (Arm A SOC1 versus [vs] Arm B BAT) and following second treatment (Arm A SOC 2 vs Arm B darolutamide) as determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (for soft tissue metastases) and Prostate Cancer Working Group 3/PCWG3 criteria (for bone metastases).

II. To evaluate the PSA50 response (PSA decline ≥ 50% from baseline) rate following initial randomization (Arm A SOC1 vs Arm B BAT) and following second treatment (Arm A SOC2 vs Arm B darolutamide).

III. To evaluate the radiographic response rate following initial randomization (Arm A SOC1 vs Arm B BAT) and following second treatment (Arm A SOC2 vs Arm B darolutamide) per RECIST 1.1 criteria.

IV. To evaluate the incidence and severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).

  1. To compare overall quality of life, measured by FACT-P total score, at 12 weeks between Arms A and B. (QOL objective) VI. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 12 weeks between Arms A and B. (QOL objective) VII. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue] scores) at 12 weeks between Arms A and B. (QOL objective) VIII. To compare patient-reported overall QOL (FACT-P scores), and fatigue (FACIT-Fatigue scores) between Arms A and B at the time of first and second disease progression. (QOL objective) IX. To characterize longitudinal change in overall QOL (FACT-P) and fatigue (FACIT-Fatigue between baseline and second disease progression in Arms A and B. (QOL objective)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive an SOC1 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel intravenously (IV) every 21 days with or without prednisone; OR 2) Abiraterone acetate orally (PO) once daily (QD) with prednisone or methylprednisolone or dexamethasone; OR 3) Enzalutamide PO QD. SOC1 treatment continues in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive an SOC2 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) cabazitaxel IV every 21 days; OR 3) lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) IV every 6 weeks for 6 doses; OR 4) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 5) Enzalutamide PO QD. SOC2 treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI), bone imaging, and biospecimen collection throughout the study.

ARM B: Patients receive testosterone cypionate intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive darolutamide PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.

After completion of study treatment, patients are followed every 3 months for 24 months from randomization and then every 6 months for 60 months from randomization.

Being tested
Abiraterone Acetate, Biospecimen Collection, Bone Scan, Cabazitaxel, Computed Tomography
Medical subject headings
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 BR9004, BR9004-1, CB 7630, CB-7630

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo biospecimen collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone imaging

  • CabazitaxelDrug

    Also called Jevtana, RPR 116258A, RPR-116258A, RPR116258A

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • DarolutamideDrug

    Also called Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788

    Given PO

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given dexamethasone

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • EnzalutamideDrug

    Also called ASP9785, MDV 3100, MDV-3100, MDV3100

    Given PO

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, AAA 617, AAA-617

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • MethylprednisoloneDrug

    Also called Adlone, Caberdelta M, DepMedalone, Depo Moderin

    Given methylprednisolone

  • PrednisoneDrug

    Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl

    Given prednisone

  • Questionnaire AdministrationOther

    Ancillary studies

  • Testosterone CypionateDrug

    Also called depAndro, Depo-Testosterone, Depotest, Depovirin

    Given IM

Study groups in NCT07852195
Study groupRoleWhat they receive
Arm A (SOC1, SOC2)Active comparatorPatients receive an SOC1 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 3) Enzalutamide PO QD. SOC1 treatment continues in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive an SOC2 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) cabazitaxel IV every 21 days; OR 3) 177Lu-PSMA-617 IV every 6 weeks for 6 doses; OR 4) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 5) Enzalutamide PO QD. SOC2 treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.
Receives: Drug: Abiraterone Acetate; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabazitaxel; Procedure: Computed Tomography; Drug: Dexamethasone; Drug: Docetaxel; Drug: Enzalutamide; Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Magnetic Resonance Imaging; Drug: Methylprednisolone; Drug: Prednisone; Other: Questionnaire Administration
Arm B (testosterone cypionate, darolutamide)ExperimentalPatients receive testosterone cypionate IM on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive darolutamide PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Drug: Darolutamide; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Drug: Testosterone Cypionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Second progression-free survival (PFS2) (Phase II)

    Definition of progression includes radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Prostate Cancer Working Group 3 (PCWG3) for bone lesions, and clinical progression determined by treating physician. The phase II part will be conducted first and only if the treatment of Bipolar Androgen Therapy (BAT) followed by darolutamide significantly improves PFS2 compared to the SOC (SOC1 followed by SOC2) arm, then the study will continue to the phase III part. The primary comparisons will be an intention-to-treat analysis including all randomized patients. The phase II part of the study will have 89.5% power to detect the above difference in PFS2 using a one-sided 0.15 level stratified log-rank test.

    Measured: From randomization to disease progression or death, whichever occurs first after initiation of second treatment (standard of care [SOC]2 or darolutamide), assessed up to 60 months

  2. Overall survival (OS) (Phase III)

    The phase II part will be conducted first and only if the treatment of BAT followed by darolutamide significantly improves PFS2 compared to the SOC (SOC1 followed by SOC2) arm, then the study will continue to the phase III part. The primary comparisons will be an intention-to-treat analysis including all randomized patients.

    Measured: From randomization until death from any cause or date last known alive, assessed up to 60 months

  3. Overall quality of life (QOL)

    Will compare overall QOL, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between the two arms. Mixed-effects models will be constructed, utilizing all available data, with fixed effects for treatment arm, assessment time, and the treatment-by-time interactions. A random intercept per patient will be included to account for within-subject correlations.

    Patients will rate physical, social/family, emotional, and functional well-being along with additional concerns on a scale from "not at all" to "very much". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e."I am able to work" rated as very much is not comparable to "I feel sad" rated as very much).

    Measured: At randomization,12, 24 and 48 weeks after randomization

Secondary outcomes (16)

  1. Progression-free survival (PFS)

    Will be determined using RECIST 1.1 criteria (for soft tissue metastases) and PCWG3 criteria (for bone metastases). Will be evaluated for each of the two treatments in a given arm.

    Measured: From randomization to disease progression or death, whichever occurs first prior to initiation of the second treatment of the study, assessed up to 60 months

  2. PFS

    Will be determined using RECIST 1.1 criteria (for soft tissue metastases) and PCWG3 criteria (for bone metastases). Will be evaluated for each of the two treatments in a given arm.

    Measured: From initiation of second treatment to disease progression, clinical progression, or death, whichever occurs first, assessed up to 60 months

  3. Radiographic response rate

    Will be determined using RECIST 1.1 criteria. Will be evaluated for each of the two treatments in a given arm.

    Measured: From initial randomization up to 60 months

  4. Radiographic response rate

    Will be determined using RECIST 1.1 criteria. Will be evaluated for each of the two treatments in a given arm.

    Measured: From initiation of second treatment up to 60 months

  5. Prostate-specific antigen (PSA) decline ≥ 50% from baseline (PSA50) response

    Will be evaluated for each of the two treatments in a given arm.

    Measured: From initial randomization up to 60 months

  6. PSA50 response

    Will be evaluated for each of the two treatments in a given arm.

    Measured: From initiation of second treatment up to 60 months

  7. PSA PFS

    Will be evaluated for each of the two treatments in a given arm.

    Measured: From initial randomization to PSA progression or date of last disease assessment prior to initiation of second treatment, assessed up to 60 months

  8. PSA PFS

    Will be evaluated for each of the two treatments in a given arm.

    Measured: From initiation of second treatment to PSA progression or date of last disease assessment, assessed up to 60 months

  9. Overall QOL

    Will compare overall QOL, measured by FACT-P total score, between the two arms at 12 weeks after randomization.

    Patients will rate physical, social/family, emotional, and functional well-being along with additional concerns on a scale from "not at all" to "very much". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e."I am able to work" rated as very much is not comparable to "I feel sad" rated as very much).

    Measured: At 12 weeks after randomization

  10. Overall QOL

    A two-sample t test will be performed to compare the changes in FACT-P scores between the two arms.

    Patients will rate physical, social/family, emotional, and functional well-being along with additional concerns on a scale from "not at all" to "very much". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e."I am able to work" rated as very much is not comparable to "I feel sad" rated as very much).

    Measured: From baseline to 12 weeks after randomization

  11. Overall QOL

    The FACT-P total scores at the time of first progression will be compared between the two arms.

    Patients will rate physical, social/family, emotional, and functional well-being along with additional concerns on a scale from "not at all" to "very much". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e."I am able to work" rated as very much is not comparable to "I feel sad" rated as very much).

    Measured: At the time of first progression

  12. Overall QOL

    The FACT-P total scores at the time of second progression will be compared between the two arms.

    Patients will rate physical, social/family, emotional, and functional well-being along with additional concerns on a scale from "not at all" to "very much". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e."I am able to work" rated as very much is not comparable to "I feel sad" rated as very much).

    Measured: From date of randomization until the date of second documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

  13. Patient-reported fatigue

    Will be evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and compared between the two arms using a two-sample t test. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.

    Measured: 12 weeks after randomization date

  14. Patient-reported fatigue

    A two-sample t test will be performed to compare the changes in FACIT-Fatigue scores between the two arms. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.

    Measured: From baseline to 12 weeks after randomization

  15. Patient-reported fatigue

    Will be compared between the two arms. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.

    Measured: At the time of first progression

  16. Patient-reported fatigue

    Will be compared between the two arms. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.

    Measured: From date of randomization until the date of second documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start6 Jan 2027 (estimated)
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852195
Sponsor's protocol ID
EA8251
Other IDs
NCI-2026-04706, EA8251, EA8251, U10CA180820
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Abiraterone Acetate, Biospecimen Collection and Bone Scan in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by ECOG-ACRIN Cancer Research Group.

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 36 inclusion and 0 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Second progression-free survival (PFS2) (Phase II) (time frame: From randomization to disease progression or death, whichever occurs first after initiation of second treatment (standard of care [SOC]2 or darolutamide), assessed up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07852195.

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 1 Oct 2026.

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