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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%
Must not have
Concurrent use of drugs in category X drug interactions with apalutamide
Use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and at 7-14 days post-intervention (post-operative)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that strongly interact with apalutamide.
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I am not taking medications that increase the risk of seizures.
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I have had cancer other than prostate or non-melanoma skin cancer in the last 2 years.
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I haven't had serious heart issues or blood clots in the last 6 months.
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My prostate cancer has spread to distant parts of my body.
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My prostate biopsy shows neuroendocrine features.
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I have a history of seizures or conditions that could lead to seizures.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in prostate specific antigen (PSA) levels
Secondary study objectives
Health-related quality of life (HRQOL)
Post-intervention plasma trough apalutamide concentrations
Reversibility of testosterone levels
Other study objectives
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%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5660
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,907 Previous Clinical Trials
41,012,104 Total Patients Enrolled
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 Adenocarcinoma Research Study Groups: Treatment (apalutamide)
Prostate Adenocarcinoma 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
~2 spots leftby Jan 2025
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