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Capivasertib + Abiraterone for Prostate Cancer (SNARE Trial)
Phase 2
Recruiting
Led By Ryan P Kopp, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights
Summary
This trial tests a drug to shrink/destroy prostate cancer before surgery. It's studied before surgery to see if it's safe and effective.
Who is the study for?
Men over 18 with high-risk, non-metastatic prostate cancer that's not spread beyond the prostate and has specific genetic features (PTEN loss). They should have a life expectancy of more than 10 years, be able to take oral medication, and have no severe health issues. Men must use condoms if with a partner who can bear children. Those with active hepatitis or HIV, other cancers, significant heart disease or recent major surgery aren't eligible.
What is being tested?
The trial is testing whether taking capivasertib along with intensified hormone therapy drugs (abiraterone acetate and leuprolide) before surgical removal of the prostate can shrink tumors in men whose cancer hasn't spread but is at high risk for progression.
What are the potential side effects?
Possible side effects include hormonal changes leading to hot flashes or sexual dysfunction, digestive issues like nausea or diarrhea from oral medications, potential liver function changes due to drug metabolism, fatigue from treatment intensity and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neoplasm, Residual
Secondary study objectives
ERG Expression and Pathologic Response
Surgical Complications
Other study objectives
Treatment related adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
neoadjuvant capivasertib combined with androgen receptor pathway therapy (leuprolide + abiraterone) prior to radical prostatectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130
abiraterone acetate
2017
Completed Phase 4
~920
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,040 Total Patients Enrolled
16 Trials studying Prostate Cancer
9,013 Patients Enrolled for Prostate Cancer
Ryan P Kopp, MDPrincipal InvestigatorVA Portland Health Care System, Portland, OR
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatments for prostate cancer, including hormone therapy, radiation, or chemotherapy.I have not had major surgery or a serious injury recently.I have had a bone marrow or organ transplant in the past.I am willing to give a tissue sample for testing.I cannot have a biopsy for research purposes.I do not have any health issues that would stop me from following the study rules.I am scheduled for prostate surgery with lymph node removal.My heart health is stable, with no recent severe issues or uncontrolled blood pressure.I am a man who will use birth control when with a woman who can have children.I haven't had any cancer other than low-risk skin cancer in the past 5 years.My prostate cancer is considered high-risk based on its grade, stage, or PSA levels.I have recently been treated with cancer drugs or monoclonal antibodies.I have discussed treatment options with my doctor and chosen surgery.I am 18 years old or older.My organ functions are within normal ranges according to recent tests.I weigh at least 45 kg and my BMI is at least 18.5.My prostate cancer is confirmed and has not spread.I am fully active or can carry out light work.I can take and keep down pills.I have not taken certain medications recently.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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