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Hormone Therapy
Apalutamide + Cetrelimab for Prostate Cancer
Phase 2
Waitlist Available
Led By Rahul Aggarwal, MD
Research Sponsored by Rahul Aggarwal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be evaluable for the primary endpoint of composite response and must have either serum Prostate-specific antigen (PSA) > 2 ng/mL during screening and/or measurable disease by RECIST 1.1 criteria.
Prior progression on at least one androgen signaling inhibitor (e.g. abiraterone acetate, apalutamide, enzalutamide, darolutamide).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether combining apalutamide with cetrelimab will result in a better response rate for men with metastatic castration-resistant prostate cancer who have evidence of treatment-emergent small cell neuroendocrine prostate cancer.
Who is the study for?
This trial is for men aged 18+ with prostate cancer that has become resistant to hormone therapy and shows small cell neuroendocrine features. They must have had no more than one prior chemo in the metastatic setting, be able to perform daily activities (ECOG <=1), and agree to use contraception. Excluded are those with certain immune conditions, recent vaccines or other treatments, infections needing IV antibiotics, gastrointestinal absorption issues, or a history of seizures.Check my eligibility
What is being tested?
The study tests if adding apalutamide (a drug blocking male hormones) to cetrelimab (an immunotherapy drug) can help patients whose prostate cancer has changed into a form not driven by male hormones. Participants will receive both drugs and their response will be monitored through clinical assessments.See study design
What are the potential side effects?
Possible side effects include fatigue, rash, diarrhea, joint pain from apalutamide; cetrelimab may cause immune-related reactions like inflammation in organs such as lungs or intestines, skin rashes or liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My PSA level is over 2 ng/mL or my cancer can be measured by scans.
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My cancer progressed despite treatment with drugs like abiraterone.
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I am 18 years old or older.
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My testosterone levels are very low, and I am on or will stay on hormone therapy if I haven't had surgery to remove my testicles.
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I am fully active or can carry out light work.
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My prostate cancer has worsened recently.
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My prostate cancer has changed into a more aggressive form with specific genetic changes.
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My organ functions are within normal ranges according to recent tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite Response Rate
Secondary outcome measures
Median Duration of Response
Median Overall Survival
Median PSA progression-free survival (PFS)
+5 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
1Treatment groups
Experimental Treatment
Group I: Single Arm: Apalutamide + CetrelimabExperimental Treatment2 Interventions
Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~3310
Cetrelimab
2022
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Rahul AggarwalLead Sponsor
11 Previous Clinical Trials
518 Total Patients Enrolled
6 Trials studying Prostate Cancer
276 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,516 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,341 Patients Enrolled for Prostate Cancer
Rahul Aggarwal, MDPrincipal InvestigatorUniversity of California, San Francisco
22 Previous Clinical Trials
1,408 Total Patients Enrolled
12 Trials studying Prostate Cancer
1,041 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiotherapy less than 2 weeks before starting the trial.I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, and my side effects from previous treatments are minimal.My PSA level is over 2 ng/mL or my cancer can be measured by scans.I have had only one taxane-based chemotherapy for advanced prostate cancer.My cancer progressed despite treatment with drugs like abiraterone.I am willing to have a biopsy of my cancer if I haven't had one before.I am HIV positive without effective treatment and have had an undetectable viral load for 6 months.I do not have another cancer that needs treatment during this study.I am not on high-dose steroids or other drugs that weaken my immune system.I am currently taking apalutamide and can continue without stopping.I have had pneumonitis treated with steroids or currently have it.I have not received a live vaccine in the last 30 days.I am 18 years old or older.My prostate cancer has spread and is resistant to hormone therapy.You are allergic to cetrelimab or apalutamide.I have not needed IV antibiotics for an infection in the last week.My testosterone levels are very low, and I am on or will stay on hormone therapy if I haven't had surgery to remove my testicles.I have a digestive condition that affects how my body absorbs nutrients.I have previously received treatments targeting my immune system.I am fully active or can carry out light work.My prostate cancer is a specific type called 'small cell carcinoma' from the start.My prostate cancer has worsened recently.I have a heart condition.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.I have an active hepatitis B or C infection with a detectable viral load.I have not taken any forbidden medications in the last week.I have not had major surgery in the last 4 weeks.My prostate cancer has changed into a more aggressive form with specific genetic changes.I have had seizures or a condition that could lead to seizures.My organ functions are within normal ranges according to recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm: Apalutamide + Cetrelimab
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.
How many people are being selected for this opportunity?
"Yes, the trial is still open and recruiting patients according to the latest update on clinicaltrials.gov. The study was first posted on March 16th, 2022 and was last updated on March 21st, 2022. 24 participants are needed in total, at one location."
Answered by AI
Are people still able to enroll in this research project?
"The latest information on clinicaltrials.gov suggests that this study is still recruiting patients. The original posting date was March 16th, 2022 and the site has been updated as recently as March 21st, 2022."
Answered by AI
Is this a new or existing study?
"Apalutamide has been the focus of medical research since 2013 when the first study, sponsored by Aragon Pharmaceuticals, was completed. With 1207 participants, this initial trial led to Apalutamide being approved for phase 3 drug trials. Currently, there are 53 active studies in progress involving Apalutamide across 588 cities and 46 countries."
Answered by AI
Is there any previous research on Apalutamide?
"Currently, there are 53 different clinical trials underway for Apalutamide. Out of those, 17 have reached Phase 3 status. The primary location for these studies is Linz, North Rhine-Westfalia; however, there are 3751 total locations running these trials."
Answered by AI
Has Apalutamide been cleared for use in the United States?
"Apalutamide's safety is based off of Phase 2 trial data, meaning that while there is some indication of safety, there is no proof of efficacy."
Answered by AI
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