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Hormone Therapy
Capivasertib + Abiraterone for Prostate Cancer (CAPItello-281 Trial)
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Provide a FFPE tissue block (preferred) or slides. Tissue from bone metastases is not acceptable
Able and willing to swallow and retain oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 80 months
Awards & highlights
CAPItello-281 Trial Summary
This trial will compare the efficacy of capivasertib+abiraterone+androgen deprivation therapy to placebo+abiraterone+androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC) whose tumours are PTEN-deficient. The primary endpoint is radiographic progression-free survival.
Who is the study for?
Men with metastatic hormone-sensitive prostate cancer and PTEN deficiency, who can take abiraterone and steroids, are eligible. They must have a recent diagnosis (within 180 days), provide specific tissue samples, show evidence of metastasis, be on ADT treatment for up to 93 days before the trial starts, have an ECOG performance status of 0-1, and agree to contraception. Exclusions include brain metastases or spinal cord compression not stable without steroids for at least four weeks.Check my eligibility
What is being tested?
The study is testing if adding Capivasertib to Abiraterone (+prednisone/prednisolone) along with ADT provides better outcomes than placebo plus Abiraterone (+prednisone/prednisolone) with ADT in men whose tumors lack PTEN protein. The main goal is improving time without disease progression using imaging criteria or until death from any cause.See study design
What are the potential side effects?
Possible side effects may include nausea, vomiting issues due to medication absorption problems; lung conditions like interstitial lung disease; heart-related issues such as QT interval prolongation or heart failure; uncontrolled high blood pressure; significant abnormalities in glucose metabolism requiring insulin treatment.
CAPItello-281 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tissue sample that is not from bone metastases.
Select...
I can take and keep down pills.
Select...
My cancer has spread, with at least one bone or soft tissue lesion suitable for CT or MRI monitoring.
Select...
I can care for myself and have not gotten worse in the past 2 weeks. My doctor thinks I have at least 3 months to live.
Select...
My tests show a PTEN deficiency in my cancer.
Select...
I am eligible for treatment with abiraterone and steroids.
CAPItello-281 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 80 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 80 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Progression-free Survival (rPFS)
Secondary outcome measures
Disease-Related Symptoms and HRQoL using the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) questionnaire
Fatigue intensity, severity and interference domains assessed by the Brief Fatigue Inventory (BFI)
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
+10 moreOther outcome measures
Body Temperature
Changes in Targeted Laboratory Results
Incidence and Severity of Adverse Events (AEs)
+4 moreSide effects data
From 2021 Phase 3 trial • 32 Patients • NCT0151780210%
Pulmonary Embolism
6%
Diarrhoea
6%
Fall
6%
Skin Laceration
3%
Urinary Retention
3%
Acute Kidney Injury
3%
Cardiac Failure Congestive
3%
Musculoskeletal Pain
3%
Oesophagitis
3%
Myocardial Infarction
3%
Nausea
3%
Vomiting
3%
Aortic Thrombosis
3%
Hypertension
3%
Dyspnoea
3%
Fatigue
3%
Weight Decreased
3%
Lower Respiratory Tract Infection
3%
Urinary Tract Infection
3%
Dehydration
3%
Cerebrovascular Accident
3%
Encephalopathy
3%
Spinal Cord Compression
3%
Syncope
3%
Cardiac Failure
3%
Upper Limb Fracture
3%
Aortic Valve Replacement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abiraterone Acetate + Prednisone/Prednisolone
CAPItello-281 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Capivasertib + AbirateroneExperimental Treatment2 Interventions
Participants receive capivasertib in combination with abiraterone (prednisone/prednisolone) on a background of ADT.
Group II: Placebo + AbirateronePlacebo Group2 Interventions
Participants receive placebo in combination with abiraterone (prednisone/prednisolone) on a background of ADT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone Acetate
2015
Completed Phase 4
~1880
Capivasertib
2021
Completed Phase 1
~130
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,592,902 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot properly absorb medications due to my stomach or bowel condition.I can provide a tissue sample that is not from bone metastases.I have completed the required pain and fatigue questionnaires.I can take and keep down pills.I have not had major surgery in the last 4 weeks.I have started hormone therapy for my cancer within the last 93 days.I have no health conditions that prevent me from taking abiraterone.I have not had any cancer progress or needed treatment in the last 3 years, except for skin cancer that was treated.My cancer has spread, with at least one bone or soft tissue lesion suitable for CT or MRI monitoring.I was diagnosed with a specific type of prostate cancer that is sensitive to hormones within the last 6 months.I can care for myself and have not gotten worse in the past 2 weeks. My doctor thinks I have at least 3 months to live.You have a condition affecting your memory, thinking, or mental health that makes it difficult for you to understand and make decisions about the study.My cancer can't be measured by standard scans due to extensive bone involvement and lack of measurable soft tissue lesions.I haven't taken certain cancer or immune system treatments recently.My tests show a PTEN deficiency in my cancer.I am allergic to capivasertib, abiraterone, or similar drugs.I had surgery or radiotherapy for prostate cancer, but not wide field radiation in the last 4 weeks.I do not have significant heart problems or abnormal heart rhythms.I don't have active brain tumors or untreated spinal issues related to my cancer.I have had lung conditions that needed steroid treatment.I have had a bone marrow or organ transplant.I am eligible for treatment with abiraterone and steroids.I do not have severe illnesses or active infections like hepatitis or HIV.I am not taking any medications that greatly affect my heart's rhythm.I have diabetes needing insulin or my HbA1c is 8.0% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Capivasertib + Abiraterone
- Group 2: Placebo + Abiraterone
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study taking place across multiple continents?
"Currently, the study is being conducted in 36 different sites. These include locations such as Baltimore, Grand Rapids and Toronto. To limit travel time and inconvenience, please select the location nearest you when enrolling."
Answered by AI
Are we still looking for participants in this clinical trial?
"Yes, this study is looking for participants right now. The listing on clinicaltrials.gov shows that it was first posted on July 13th, 2020 and updated November 7th, 2020."
Answered by AI
To whom does this clinical trial offer enrollment?
"Individuals that are both age 18-130 and hypersensitive qualify to participate in this study. The research team wants to enroll a total of 1,000 patients."
Answered by AI
What other scientific studies have included Capivasertib?
"Capivasertib was first studied in 2005 at the Rosemere Cancer Centre. As of now, there have been 18395 completed studies with 122 ongoing trials recruiting patients. A large majority of these active trials are based out of Baltimore, Maryland."
Answered by AI
Is this research only being conducted on young adults, or are elder patients welcome as well?
"In order to take part in this study, patients must be between the ages of 18-130. However, if you are under 18 or over 65, don't worry! There are plenty of other trials that might be a better fit for you - 159 and 1537 respectively."
Answered by AI
Has Capivasertib received government permission to be marketed and sold in the United States?
"Capivasertib's safety is rated 3 out of 3 by our Power team. This is due to the fact that it has reached Phase 3 trials, which suggests both efficacy and multiple rounds of safe testing."
Answered by AI
How many people will be trialing this medication at most?
"Yes, the trial is still open for recruitment according to information on clinicaltrials.gov. This particular study was posted on July 13th, 2020 and was last updated November 7th, 2020. They are looking for a total of 1000 patients from 36 different sites."
Answered by AI
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