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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 57 months

Awards & highlights

TITAN 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.Check my eligibility

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.See study design

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.

TITAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread to my bones, confirmed by scans.

Select...

I am fully active or can carry out light work.

Select...

My doctor confirmed I have prostate cancer.

TITAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 57 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Radiographic Progression-free Survival (rPFS)

Secondary outcome measures

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%

Amylase increase

15%

Dizziness

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Personality change

Erectile dysfunction

Headache

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anxiety

Atrial fibrillation

Bruising

Anorexia

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

TITAN 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

~530

Apalutamide

2015

Completed Phase 2

~3310

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

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

745 Previous Clinical Trials

3,958,853 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

Frequently Asked Questions

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

Are there long-term risks to taking Apalutamide?

"Apalutamide, which is currently in Phase 3 trials, received a safety score of 3 from our team at Power. This means that while there is still some testing to be done in terms of efficacy, the data collected thus far suggests it is safe."

Answered by AI

Is this research novel in any way?

"Aragon Pharmaceuticals, Inc. first sponsored a study into apalutamide in 2013. This initial trial involved 1207 participants and was conducted in 2013. Apalutamide received Phase 3 drug approval following the success of this first study. As it stands, there are 46 active trials being conducted across 580 cities and 40 countries worldwide."

Answered by AI

What other research has included Apalutamide in its investigations?

"Currently, there are 46 ongoing studies involving apalutamide. Of these, 16 are in phase 3. The majority of clinical trials for apalutamide are based in Marshfield, Wisconsin; however, there are 2752 locations running trials for the drug."

Answered by AI

What are the intentions of this experiment?

"The aim of this long-term study (up to 54 months) is to evaluate overall survival rates. Secondary outcomes being measured include time until patients experience a skeletal-related event (SRE; defined as pathological fracture, spinal cord compression, radiation therapy for bone or surgery on bone), time until initiation of cytotoxic chemotherapy, and duration of response."

Answered by AI

Is this experiment still enrolling new participants?

"According to the website clinicaltrials.gov, this specific trial is not looking for any more patients at the moment. This particular study was first posted on 11/27/2015 and was edited most recently on 10/25/2022; however, there are many other trials (1410 in total) that are currently seeking patients."

Answered by AI

In how many different locations is this trial taking place?

"Presently, this study is looking for participants from a total of 46 sites. These locations are situated in Chicago, Norwalk, Bronx and other cities. To cut down on travel time, select the location nearest to you when enrolling."

Answered by AI

How many individuals are allowed to enroll in this clinical experiment?

"As of right now, this study is not recruiting any more patients. This particular trial was first posted on November 27th, 2015 and was edited most recently on October 25th, 20222. If you are interested in other studies, 1364 trials for prostate cancer and 46 for Apalutamide are currently looking for participants."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Agarwal, Neeraj, Kelly McQuarrie, Anders Bjartell, Simon Chowdhury, Andrea J Pereira de Santana Gomes, Byung Ha Chung, Mustafa Özgüroğlu, et al.. 2019. “Health-related Quality of Life After Apalutamide Treatment in Patients with Metastatic Castration-sensitive Prostate Cancer (TITAN): A Randomised, Placebo-controlled, Phase 3 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30620-5.

BMC UrologyJournal

Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-label Study

Uemura, Hiroji, Yosuke Koroki, Yuki Iwaki, Keiichiro Imanaka, Takeshi Kambara, Angela Lopez-Gitlitz, Andressa Smith, and Hirotsugu Uemura. 2020. “Skin Rash Following Administration of Apalutamide in Japanese Patients with Advanced Prostate Cancer: An Integrated Analysis of the Phase 3 SPARTAN and TITAN Studies and a Phase 1 Open-label Study”. BMC Urology. Springer Science and Business Media LLC. doi:10.1186/s12894-020-00689-0.

Journal of UrologyJournal

Apalutamide Plus Androgen Deprivation Therapy for Metastatic Castration-sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study

Agarwal, Neeraj, Kelly McQuarrie, Anders Bjartell, Simon Chowdhury, Andrea J. Pereira de Santana Gomes, Byung Ha Chung, Mustafa Özgüroğlu, et al.. 2021. “Apalutamide Plus Androgen Deprivation Therapy for Metastatic Castration-sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ju.0000000000001841.

New England Journal of MedicineJournal

Apalutamide for Metastatic, Castration-sensitive Prostate Cancer