Phase II Study of Capivasertib, Abiraterone, and Leuprolide for High-Risk Prostate Cancer
This study is looking at a new way to treat high-risk prostate cancer before surgery. It combines capivasertib, abiraterone acetate, and leuprolide to shrink tumors. You might be able to join if you are an adult man with high-risk localized prostate cancer that has a specific change called PTEN loss. Researchers want to see if this combination treatment can shrink or destroy the cancer before surgery. The main goal is to see how many people have a complete response or very little cancer left after treatment. The current status of this study is unclear, and it plans to enroll 30 participants.
- Study design
- This is a Phase II interventional study with a single arm, meaning all 30 participants will receive the same treatment. It is not specified if the study is blinded.
- What's involved
- You would take capivasertib for 4 days on and 3 days off each week, along with daily abiraterone acetate and prednisone, and leuprolide. This treatment will last for about 16 weeks before surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome is measured at 5 months after starting treatment, which is around the time of surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05593497
A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss
Recruiting
PHASE2Ages 18+InterventionalTreatmentVA Office of Research and DevelopmentGovernment-funded
~30 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Capivasertibabiraterone acetate
At a glance
Recruiting sites
6 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathologic Complete Response or Minimal Residual Disease (MRD)
Measured over 5 months
Conditions
Where it's being run
9 sites across 8 statesTexas2
California1
Illinois1
Missouri1
New York1
Oregon1
South Carolina1
Washington1
Study leadership
- Ryan P Kopp, MD · PRINCIPAL_INVESTIGATOR · VA Portland Health Care System, Portland, OR
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Gleason sum \>7 (ISUP Grade Group \>3)
Clinical stage T3 (resectable), per American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 8th edition
Gleason score 4+3=7 (ISUP Grade Group 3) AND
Estimated progression-free probability after radical prostatectomy that is less than or equal to 50% at 5 years by MSK nomogram 5. No definitive evidence of metastasis on nuclear bone scan (required on all subjects) 6. No evidence of lymph nodes \> 2 centimeter (cm) in diameter on pelvic computed tomography (CT) scan (scan only required in patients with a PSA \> 20 ng/ml) 7. Prostatectomy with extended lymph node dissection planned as primary therapy
The subject had a discussion with a clinician about other options, such as radiotherapy, and elected to undergo surgical treatment
The subject has been offered consultation with radiation oncology and declined consultation or radiation treatment, or determined it was not in best medical interest 8. Be willing to provide tissue from a diagnostic biopsy core or excisional biopsy of a tumor lesion obtained up to 6 months/180 days prior to initiation of treatment on Day 1. Subjects for whom samples cannot be provided (e.g., inaccessible or subject safety concern) may submit an older archived specimen only upon agreement from the Sponsor-Investigator. 9. Tumor tissue must be provided for biomarker analysis. Phosphatase and tensin homologue (PTEN) immunohistochemistry (IHC) staining must be less than or equal to 10% as determined by the central lab. If insufficient tumor tissue content is provided for analysis, acquisition of additional archived tumor tissue (block and /or slides) for the biomarker analysis is required 10. Have a performance status of 0 or 1 on the ECOG Performance Scale with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 11. Life expectancy of greater than 10 years per the treating physician 12. Minimum body weight of 45 kilogram (kg) with minimum Body Mass Index (BMI) of 18.5 13. Non-sterile men who are not totally sexually abstinent (i.e., refraining from heterosexual intercourse during the entire period of risk associated with study interventions) and intend to be sexually active with a women of childbearing potential partner must use a condom upon entering the study and until 16 weeks after the last dose of capivasertib. Contraception should be considered in females' partners of men taking capivasertib who are of childbearing potential 14. Able and willing to swallow and retain oral medication 15. Demonstrate adequate organ function as defined by laboratory parameters including ANC, platelets, hemoglobin, transaminases, albumin, hemoglobin A1C, CrCl or eGFR, PTT and INR (unless anticoagulated, then therapeutic range is acceptable). All screening labs should be performed within 30 days of treatment initiation
Exclusion
Anti-androgen therapy including orchiectomy, luteinizing hormone-releasing hormone (LHRH) therapy, abiraterone, ketoconazole, estrogen therapy (Short-term ADT allowed, less than or equal to 2 months)
Radiation (external beam or brachytherapy)
Cytotoxic chemotherapy
Focal or ablative therapy
Any experimental therapy for treatment of prostate cancer. 5. History of another primary malignancy except for malignancy treated with curative intent with no known active disease greater than or equal to 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy 6. Any of the following cardiac criteria:
Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 consecutive ECGs
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third-degree heart block)
Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of \< 50%
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade less than or equal to 2
Uncontrolled hypotension - systolic blood pressure (SBP) \<90 mmHg and/or diastolic blood pressure (DBP) \<50 mmHg
Uncontrolled hypertension (SBP greater than or equal to 160 mmHg or DBP greater than or equal to 95 mmHg).
Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \[MUGA\] scan if an echocardiogram cannot be performed or is inconclusive). 7. Clinically significant abnormalities of glucose metabolism as defined by any of the following:
Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment
HbA1c greater than or equal to 8.0% (63.9 mmol/mol) 8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib and abiraterone. 9. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 10. Previous allogeneic bone marrow transplant or solid organ transplant 11. Received major surgery within 6 weeks prior to screening, or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study except for prostatectomy; they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 12. Is currently participating and receiving study therapy, or has participated in a study of an investigational agent or study drugs within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment 13. Has had a prior anti-cancer monoclonal antibody (mAb) within 30 days prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 30 days earlier. 14. Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, immunosuppressant medication (other than corticosteroids), or radiation therapy within 30 days prior to study Day 1, or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent.
Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of study treatment
Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment
Any concomitant medication that may interfere with abiraterone safety and efficacy based on the prescribing information of abiraterone and local clinical guidelines 16. History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class. 17. Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone and leuprolide. 18. Is unable to undergo research related biopsy as this is necessary to complete translational study objectives. 19. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
What this trial measures
- Pathologic Complete Response or Minimal Residual Disease (MRD)5 months
No cancer detected on radical prostatectomy specimen, or minimal residual disease 5mm.