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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
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.
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.
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) between patients receiving apalutamide and apalutamide + carotuximab
Secondary outcome measures
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 moreSide effects data
From 2021 Phase 2 trial • 86 Patients • NCT0327925074%
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%
Amylase increase
15%
Dizziness
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%
Personality change
6%
Erectile dysfunction
6%
Headache
6%
Dysgeusia
6%
Dyspnea
6%
HbA1c increased
6%
Hypertriglyceridemia
6%
Insomnia
6%
Irritability
3%
Anxiety
3%
Atrial fibrillation
3%
Bruising
3%
Anorexia
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)
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
~3310
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer is resistant to hormone therapy and my PSA levels are increasing.I am currently receiving treatment for another cancer.I have been diagnosed with Osler-Weber-Rendu syndrome.I have had 1 or 2 prior hormone therapies for cancer, but not apalutamide.I have never been treated with carotuximab or any CD105 targeted antibody.I have a condition that causes me to bleed easily.My prostate cancer is not showing through PSA levels but is getting worse on scans.I cannot or choose not to undergo taxane therapy as advised by my doctor.I have previously taken apalutamide.I agree to use birth control during and for 3 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Apalutamide monotherapy
- Group 2: Combination therapy (Apalutamide + Carotuximab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Apalutamide have any dangerous side effects?
"Apalutamide's safety is estimated to be a 2. In other words, while there is data suggesting that it is safe, none of the trials thus far have shown that it effective."
Answered by AI
Are patient volunteers still being welcomed for this research project?
"No, this particular clinical trial is not looking for more participants at the moment. The last time it was updated on September 6th, 2022 and originally posted November 1st, 2022. Although this study isn't enrolling patients right now, there are many other trials with open recruitment calls that could use your help."
Answered by AI
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