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Antiandrogen

Apalutamide for Prostate Cancer

Phase 2

Recruiting

Led By John K Parsons

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Karnofsky >= 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and at 7-14 days post-intervention (post-operative)

Awards & highlights

Study Summary

This trial is testing how well apalutamide works in treating prostate cancer before surgery. Low dose apalutamide may lower PSA levels in men with prostate cancer that is confined to the prostate gland.

Who is the study for?

Men over 18 with prostate cancer confined to the gland, suitable for surgery, and a PSA level <=20 ng/ml. They must be in good physical condition (Karnofsky >=70%), have no severe heart issues or recent strokes, not taking certain drugs that interact with apalutamide or lower seizure threshold, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing if low doses of Apalutamide can reduce PSA levels when given for 3-4 weeks before prostate removal surgery. It's a phase IIa study checking if this treatment could delay more aggressive therapy in men with localized prostate cancer.See study design

What are the potential side effects?

Apalutamide may cause fatigue, hot flushes, high blood pressure, nausea, diarrhea, weight loss and joint pain. Since it blocks testosterone effects on cancer growth, it might also affect sexual function.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I am mostly able to care for myself but may not be able to do active work.

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My prostate cancer is confirmed and limited to the prostate, suitable for surgery.

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My prostate cancer has a Gleason score of 8 or less, with no pattern 5.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in prostate specific antigen (PSA) levels

Secondary outcome measures

Health-related quality of life (HRQOL)

Post-intervention plasma trough apalutamide concentrations

Reversibility of testosterone levels

Other outcome measures

Tobacco

Gleason score of pre- and post-intervention tumor(s) with matched location

Intra-prostatic immune cell infiltration

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)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (apalutamide)Experimental Treatment3 Interventions

Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Apalutamide

2015

Completed Phase 2

~3310

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,664 Previous Clinical Trials

40,926,093 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,095 Patients Enrolled for Prostate Cancer

John K ParsonsPrincipal InvestigatorUniversity of Arizona Cancer Center - Prevention Research Clinic

1 Previous Clinical Trials

154 Total Patients Enrolled

Juan ChipolliniPrincipal InvestigatorUniversity of Arizona Cancer Center - Prevention Research Clinic

Media Library

Apalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04530552 — Phase 2

Prostate Cancer Research Study Groups: Treatment (apalutamide)

Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT04530552 — Phase 2

Apalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530552 — Phase 2

Frequently Asked Questions

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

How many participants are enrolled in this trial?

"Affirmative, the information on clinicaltrials.gov states that this trial is presently open for participation. The study was first published on June 1st 2021 and last updated November 10th 2022; 40 volunteers are required to be recruited at 7 different medical sites."

Answered by AI

In what locales have the experiments utilizing this trial been conducted?

"Seven medical facilities are currently running this clinical trial, including the University of California San Diego in San Diego, UC San Diego Medical Center - Hillcrest in Bethesda and NCI - Center for Cancer Research in Baltimore. Additionally there are four other sites offering enrollment into this study."

Answered by AI

Have there been any other investigations regarding Apalutamide?

"Apalutamide was initially trialled in 2014 at NCT02257736 and has since seen 146 trials to completion. At present, 44 studies are ongoing with numerous of them being conducted in San Diego, California."

Answered by AI

Has Apalutamide been given the go-ahead by the FDA?

"Our team at Power assigned Apalutamide a score of 2 due to Phase 2 trial data indicating its relative safety, with no existing efficacy data."

Answered by AI

Are there any precedents for this clinical research endeavor?

"Research into Apalutamide began in 2014, with the initial clinical trial sponsored by Aragon Pharmaceuticals. After proving successful, this drug received its Phase 3 approval that same year. Currently there are 44 active studies for Apalutamide being done across 38 countries and 552 cities."

Answered by AI

Is enrollment for this study currently available to the public?

"Per the details hosted on clinicaltrials.gov, this medical experiment is actively searching for suitable participants. The trial was first posted to the website on June 1st 2021 and has been modified as recently as November 10th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland

2021. "Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04530552.

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