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Hormone Therapy

Apalutamide + Carotuximab for Prostate Cancer

Phase 2
Recruiting
Led By Edwin Posadas, MD FACP
Research Sponsored by Edwin Posadas, MD
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 from the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to see if it can help patients with prostate cancer who have progressed on other treatments.

Who is the study for?
Men with castration-resistant prostate cancer that's gotten worse despite ARSI therapy (excluding bicalutamide, nilutamide, flutamide) can join. They should have tried at most two other AR therapies but not apalutamide and must opt out of or be unfit for taxane therapy. Participants need to use contraception during and for three months after the trial.
What is being tested?
The study is testing if adding carotuximab to apalutamide improves survival without cancer progression in men whose prostate cancer has worsened on ARSI treatment. It starts with a safety check on the first 10 patients before moving into a larger Phase II trial.
What are the potential side effects?
Possible side effects include those related to apalutamide such as fatigue, high blood pressure, skin rash, falls and fractures; plus any potential risks from carotuximab like bleeding due to its anti-angiogenic properties.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment. 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) between patients receiving apalutamide and apalutamide + carotuximab
Secondary study objectives
Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide
Overall radiographic response rate (ORR) in the overall population
Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab
+3 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
74%
Hot flashes
71%
Fatigue
44%
Anemia
38%
Hyperglycemia
26%
AST increase
26%
Hypertension
26%
Lipase increase
24%
ALT increase
24%
Dry skin
21%
Rash
18%
ACTH increase
18%
Cholesterol high
15%
Dizziness
15%
Amylase increase
12%
Memory impairment
12%
White blood cell decrease
12%
Constipation
12%
Lymphocyte count decrease
9%
Myalgia
9%
Paresthesia
9%
Weight loss
9%
Arthralgia
9%
Hypothyrodism
9%
LDH increase
6%
Erectile dysfunction
6%
Headache
6%
Personality change
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anorexia
3%
Atrial fibrillation
3%
Anxiety
3%
Bruising
3%
Hypercalcemia
3%
Dehydration
3%
TSH increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)
Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination therapy (Apalutamide + Carotuximab)Experimental Treatment2 Interventions
Group II: Apalutamide monotherapyActive Control1 Intervention
After progression, subjects will crossover to combination therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~5710

Find a Location

Who is running the clinical trial?

Edwin Posadas, MDLead Sponsor
2 Previous Clinical Trials
17 Total Patients Enrolled
2 Trials studying Prostate Cancer
17 Patients Enrolled for Prostate Cancer
Enviro Therapeutics, Inc.UNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Edwin Posadas, MD FACPPrincipal InvestigatorCedars-Sinai Medical Center
3 Previous Clinical Trials
28 Total Patients Enrolled
3 Trials studying Prostate Cancer
28 Patients Enrolled for Prostate Cancer

Media Library

Apalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05534646 — Phase 2
Prostate Cancer Research Study Groups: Apalutamide monotherapy, Combination therapy (Apalutamide + Carotuximab)
Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT05534646 — Phase 2
Apalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534646 — Phase 2
~67 spots leftby Jan 2027
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