Apalutamide for Castration-resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cedars-Sinai Medical Center, Los Angeles, CA
Castration-resistant Prostate Cancer+1 More
Apalutamide - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.

Eligible Conditions

  • Castration-resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Castration-resistant Prostate Cancer

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 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.

Week 4
Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide
Day 30
Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab
Day 30
Proportion of patients resistant to apalutamide benefit from the addition of carotuximab
Day 30
Overall radiographic response rate (ORR) in the overall population
Radiographic progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
To determine the biochemical PFS (by PCWG3) in the overall population
To determine the radiographic progression free survival (rPFS) in the overall population

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Castration-resistant Prostate Cancer

Trial Design

2 Treatment Groups

Apalutamide monotherapy
1 of 2
Combination therapy (Apalutamide + Carotuximab)
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Apalutamide · No Placebo Group · Phase 2

Combination therapy (Apalutamide + Carotuximab)Experimental Group · 2 Interventions: Carotuximab, Apalutamide · Intervention Types: Drug, Drug
Apalutamide monotherapy
Drug
ActiveComparator Group · 1 Intervention: Apalutamide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2019
Completed Phase 2
~450

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
Closest Location: Cedars-Sinai Medical Center · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2006First Recorded Clinical Trial
1 TrialsResearching Castration-resistant Prostate Cancer
515 CompletedClinical Trials

Who is running the clinical trial?

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

Eligibility Criteria

Age 18+ · Male Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had castration-resistant prostate cancer for at least 12 months and your PSA has risen on a contemporary ARSI
Patient must have had 1 prior AR targeted therapy with the exception of apalutamide.
You must be willing to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.