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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
Must not have
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: i. Absolute neutrophil count < 1.5x 109/L ii. Platelet count < 100x 109/L iii. Haemoglobin < 9 g/dL (< 5.59 mmol/L) iv. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator's judgement v. Total bilirubin > 1.5x ULN (participants with confirmed Gilbert's syndrome may be included in the study with a higher value) vi. Creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)
Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 80 months
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a tissue sample that is not from bone metastases.
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I can take and keep down pills.
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My cancer has spread, with at least one bone or soft tissue lesion suitable for CT or MRI monitoring.
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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.
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My tests show a PTEN deficiency in my cancer.
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I am eligible for treatment with abiraterone and steroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot properly absorb medications due to my stomach or bowel condition.
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I have not had major surgery in the last 4 weeks.
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I have no health conditions that prevent me from taking abiraterone.
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My cancer can't be measured by standard scans due to extensive bone involvement and lack of measurable soft tissue lesions.
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I am allergic to capivasertib, abiraterone, or similar drugs.
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I do not have significant heart problems or abnormal heart rhythms.
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I have had lung conditions that needed steroid treatment.
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I have had a bone marrow or organ transplant.
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I am not taking any medications that greatly affect my heart's rhythm.
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I have diabetes needing insulin or my HbA1c is 8.0% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 80 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 80 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression-free Survival (rPFS)
Secondary study objectives
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
+7 more
Other study objectives
Body Temperature
Changes in Targeted Laboratory Results
Incidence and Severity of Adverse Events (AEs)
+4 more

Side effects data

From 2021 Phase 3 trial • 32 Patients • NCT01517802
10%
Pulmonary Embolism
6%
Diarrhoea
6%
Fall
6%
Skin Laceration
3%
Cardiac Failure Congestive
3%
Myocardial Infarction
3%
Urinary Retention
3%
Nausea
3%
Oesophagitis
3%
Musculoskeletal Pain
3%
Acute Kidney Injury
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
4,411 Previous Clinical Trials
289,122,061 Total Patients Enrolled
57 Trials studying Prostate Cancer
25,464 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04493853 — Phase 3
Prostate Cancer Research Study Groups: Capivasertib + Abiraterone, Placebo + Abiraterone
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT04493853 — Phase 3
Abiraterone Acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493853 — Phase 3
~187 spots leftby Dec 2025
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