Apalutamide for Prostate Cancer

Universitaetsklinikum der RWTH Aachen, Aachen, Germany
Apalutamide +2 morePhase 3RecruitingResearch Sponsored by Janssen Research & Development, LLC

Study Summary

This trial will compare the effectiveness of apalutamide + ADT vs placebo + ADT in men with high-risk prostate cancer before and after surgery. The main outcome measures are pCR rate and MFS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Metastasis-Free Survival (MFS)
Percentage of Participants with Pathologic complete response (pCR)
Secondary outcome measures
Event Free Survival (EFS)
MFS Based on Conventional Imaging
Number of Participants with Adverse Events
+7 more

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250
91%
Hot flashes
88%
Fatigue
62%
Anemia
47%
Hyperglycemia
41%
Dry skin
32%
Cholesterol high
29%
Insomnia
29%
Rash
26%
Dizziness
26%
TSH increased
26%
Hypertriglyceridemia
24%
Arthralgia
24%
Headache
21%
Lipase increase
21%
Memory impairment
15%
Hypertension
12%
Anxiety
12%
Dysgeusia
12%
AST increase
12%
Irritability
12%
Nausea
12%
Amylase increase
12%
White blood cell decrease
9%
ALT increase
9%
Alopecia
9%
Erectile dysfunction
9%
Hypothyrodism
6%
Anorexia
6%
Cognitive disturbance
6%
Constipation
6%
HbA1c increased
6%
GERD
6%
Generalized Muscle Weakness
6%
Hypercalcemia
6%
Fall
6%
Bruising
6%
Lymphocyte count decrease
6%
Insulin increase
6%
LDH increase
6%
Vitamin D decrease
6%
Paresthesia
6%
Weight loss
3%
Syncope
3%
Dyspnea
3%
Myalgia
3%
Personality change
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (LHRHa, Apalutamide)
Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo + ADTExperimental Treatment2 Interventions
Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment.
Group II: Apalutamide + ADTExperimental Treatment2 Interventions
Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
FDA approved
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~530
Placebo
1995
Completed Phase 3
~2670

Find a site

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
955 Previous Clinical Trials
6,373,752 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy Director
Janssen Research & Development, LLC
732 Previous Clinical Trials
3,955,375 Total Patients Enrolled
7 Trials studying Prostate Cancer
2,688 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT03767244 — Phase 3
Prostate Cancer Research Study Groups: Apalutamide + ADT, Placebo + ADT
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT03767244 — Phase 3
Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03767244 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What benefits could this clinical trial offer patients?

"The primary outcome measure for this trial, which will be tracked over the course of approximately 4 years, is Metastasis-Free Survival (MFS). Additionally, secondary outcomes including Time to Distant Metastasis (TTDM), Event Free Survival (EFS), and Prostate Specific Antigen (PSA)-Free Survival will also be monitored."

Answered by AI

Could you please explain the Apalutamide's side effects?

"Apalutamide's safety is estimated to be a 3. This rating comes from the fact that Apalutamide is in Phase 3 of clinical trials."

Answered by AI

What is the precedent for Apalutamide research?

"At the current moment, there are 46 global clinical trials for Apalutamide with 16 of them being in Phase 3. Most of these studies are based out of Marshfield, Wisconsin; however, there are 2752 locations running trials for Apalutamide worldwide."

Answered by AI

Can anyone participate in this research project at present?

"That is correct. The information available on clinicaltrials.gov suggests that this trial is still in the process of recruiting patients. This study was first posted on June 11th, 2019 and has since been edited October 25th, 2022. So far, 46 sites have enrolled 2500 patients total."

Answered by AI

Is this clinical trial testing a new medication?

"There are currently 46 ongoing trials for Apalutamide in 580 cities across 40 countries. The first trial was conducted in 2013 and completed its final stage of drug approval in Phase 3. A total of 18296 trials have been conducted since the original study."

Answered by AI

What is the uppermost limit for patients who can enroll in this clinical trial?

"In order to move forward with this research, 2500 willing and eligible patients must enroll. If you are based in Greensboro, North Carolina or Los Angeles, California, know that there are multiple locations where you can take part in this study."

Answered by AI

In how many different medical sites is this study being conducted today?

"Presently, this clinical trial is running in 46 locations which include Greensboro, Los Angeles and Houston. To limit travel as a requirement of participation, make sure to select the clinic that is nearest to your location."

Answered by AI
~259 spots leftby Apr 2024