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New treatment option for High-Risk Prostate Cancer
Official title 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
ClinicalTrials.gov ID: NCT05593497
What this study is testing
What is Capivasertib?
Capivasertib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for high-risk prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed...
- Age greater than or equal to 18 years. Members of all races and ethnic groups will be included.
- Participants must have histologically confirmed non-metastatic adenocarcinoma of the prostate
- (a) Any one of the following three high risk features:
- Gleason sum \>7 (ISUP Grade Group \>3)
You likely can't join if
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal...
- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a...
- Known to have active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at...
- Prior prostate cancer treatment including:
- Anti-androgen therapy including orchiectomy, LHRH therapy, abiraterone, ketoconazole, estrogen therapy (Short-term ADT allowed, less than or equal to...
- Radiation (external beam or brachytherapy)
See the full eligibility criteria
Who can join
- Informed Consent: provision of signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Age greater than or equal to 18 years. Members of all races and ethnic groups will be included.
- Participants must have histologically confirmed non-metastatic adenocarcinoma of the prostate
- (a) Any one of the following three high risk features:
- Gleason sum \>7 (ISUP Grade Group \>3)
- Clinical stage T3 (resectable), per AJCC Cancer Staging Manual, 8th ed.
- PSA \> 20 ng/ml oSubjects who meet high risk criteria solely by PSA (i.e., stage \<T3 AND Gleason sum less than or equal to 7) must have a progression-free probability after radical prostatectomy that is less than or...
- 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
- No definitive evidence of metastasis on nuclear bone scan (required on all people)
- No evidence of lymph nodes \> 2 cm in diameter on pelvic CT scan (scan only required in patients with a PSA \> 20 ng/ml)
- 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
- 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. people for whom samples cannot be provided...
- Tumor tissue must be provided for biomarker analysis. PTEN 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...
- 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.
- Life expectancy of greater than 10 years per the treating physician.
- Minimum body weight of 45 kg with minimum Body Mass Index (BMI) of 18.5
- 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...
- Able and willing to swallow and retain oral medication
- 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...
What rules you out
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases, uncontrolled pulmonary...
- Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an...
- Known to have active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening. Known to have human immunodeficiency virus (HIV) with a CD4+...
- Prior prostate cancer treatment including:
- Anti-androgen therapy including orchiectomy, 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)
- 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...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Previous allogeneic bone marrow transplant or solid organ transplant
- 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...
- 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
- 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...
- 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...
- Treatment with any of the following:
- 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...
- 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 how well it works based on the prescribing information of abiraterone and local clinical guidelines
- History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.
- Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone and leuprolide.
- Is unable to undergo research related biopsy as this is necessary to complete translational study objectives.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- West Los Angeles, California, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Los Angeles, California, United States; The Bronx, New York, United States; Portland, Oregon, United States; Charleston, South Carolina, United States; San Antonio, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.