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Apalutamide + ADT for Prostate Cancer (TITAN Trial)

Phase 3
Waitlist Available
Research Sponsored by Aragon Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic disease documented by >= 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by CT or MRI
Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
Must not have
History of seizures or medications known to lower seizure threshold
Visceral metastases as only sites of metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 57 months
Awards & highlights
Pivotal Trial

Summary

This trial will study whether the addition of apalutamide to androgen deprivation therapy (ADT) can improve outcomes for men with metastatic hormone-sensitive prostate cancer (mHSPC).

Who is the study for?
Men with metastatic hormone-sensitive prostate cancer (mHSPC) who are fit for treatment (ECOG PS 0 or 1), have bone lesions confirmed by scans, and may have had limited prior treatments like docetaxel or ADT. Not eligible if they've had certain other cancers within 5 years, brain metastases, only lymph node involvement, visceral-only metastases, previous next-gen anti-androgens or seizure history.
What is being tested?
The trial is testing whether adding a drug called Apalutamide to standard Androgen Deprivation Therapy (ADT) can help improve survival without the cancer getting worse on scans. Participants will either receive Apalutamide plus ADT or a placebo plus ADT to compare outcomes.
What are the potential side effects?
Apalutamide can cause fatigue, high blood pressure, skin rash, falls and fractures due to bone weakening. It might also lead to seizures in rare cases. Standard ADT side effects include hot flashes, reduced sexual desire and function, weight gain and mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to my bones, confirmed by scans.
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I am fully active or can carry out light work.
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My doctor confirmed I have prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures or take medication that could lower my seizure threshold.
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My cancer has spread only to my internal organs.
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My cancer has spread only to my lymph nodes.
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My prostate cancer is of a specific type (small cell, ductal, or neuroendocrine).
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I have cancer that has spread to my brain.
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I have been treated with specific medications for prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 57 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 57 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS)
Radiographic Progression-free Survival (rPFS)
Secondary study objectives
Time to Chronic Opioid Use
Time to Initiation of Cytotoxic Chemotherapy
Pain
+1 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

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 plus ADTExperimental Treatment2 Interventions
Participants will receive matching Placebo with ADT.
Group II: Apalutamide plus ADTExperimental Treatment2 Interventions
Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~610
Apalutamide
2015
Completed Phase 2
~5750
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
4,322 Total Patients Enrolled
4 Trials studying Prostate Cancer
232 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,979,878 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,636 Patients Enrolled for Prostate Cancer

Media Library

Androgen Deprivation Therapy (ADT) Clinical Trial Eligibility Overview. Trial Name: NCT02489318 — Phase 3
Prostate Cancer Research Study Groups: Apalutamide plus ADT, Placebo plus ADT
Prostate Cancer Clinical Trial 2023: Androgen Deprivation Therapy (ADT) Highlights & Side Effects. Trial Name: NCT02489318 — Phase 3
Androgen Deprivation Therapy (ADT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02489318 — Phase 3
~105 spots leftby Dec 2025
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