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Antiandrogen

Apalutamide for Castration-Resistant Prostate Cancer (SPARTAN 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
Patients who received a first generation anti-androgen must have at least a 4-week washout prior to randomization AND must show continuing disease (PSA) progression after washout
Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3 PSA rises, at least 1 week apart, with the last PSA > 2 nanogram per milliliter (ng/mL)
Must not have
Symptomatic local or regional disease requiring medical intervention
Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 43 months
Awards & highlights
Pivotal Trial

Summary

This trial will test whether apalutamide can help treat prostate cancer that is not responding to hormone therapy and has not spread.

Who is the study for?
Men with non-metastatic castration-resistant prostate cancer, showing a high risk of developing metastases and having a PSA doubling time of 10 months or less. Participants must be on continuous ADT with rising PSA levels, maintain low testosterone, and have no prior treatments that disqualify them such as second-generation anti-androgens or chemotherapy for prostate cancer.
What is being tested?
The trial is testing the effectiveness and safety of Apalutamide compared to a placebo in men with high-risk non-metastatic castration-resistant prostate cancer. The goal is to see if Apalutamide can prevent the cancer from spreading.
What are the potential side effects?
Possible side effects include fatigue, joint pain, rash, weight loss, diarrhea, hot flushes, increased blood pressure and falls. More serious risks may involve fractures or seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've stopped my first anti-androgen treatment for 4 weeks and my cancer is still getting worse.
Select...
My prostate cancer is growing despite hormone therapy, with increasing PSA levels.
Select...
My prostate cancer is aggressive with a PSA doubling time of 10 months or less.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer symptoms need medical treatment.
Select...
I have not had treatments like radiopharmaceuticals for my prostate cancer before it spread.
Select...
My cancer has spread to distant parts of my body, including the brain or spine.
Select...
I am not taking any medications that are not allowed in this study.
Select...
I have a history of seizures or a condition that could lead to seizures.
Select...
I have been treated with CYP17 inhibitors before.
Select...
I have been treated with second generation anti-androgens.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 43 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
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Secondary study objectives
Overall Survival
Progression-free Survival (PFS)
Time to Initiation of Cytotoxic Chemotherapy
+2 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
Placebo Group
Group I: Treatment Arm A: ApalutamideExperimental Treatment1 Intervention
Group II: Treatment Arm B: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apalutamide
2015
Completed Phase 2
~5660

Find a Location

Who is running the clinical trial?

Aragon Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
4,167 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,284 Patients Enrolled for Prostate Cancer
Aragon Pharmaceuticals, Inc. Clinical TrialStudy DirectorAragon Pharmaceuticals, Inc.
3 Previous Clinical Trials
1,560 Total Patients Enrolled

Media Library

Apalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT01946204 — Phase 3
Prostate Cancer Research Study Groups: Treatment Arm A: Apalutamide, Treatment Arm B: Placebo
Prostate Cancer Clinical Trial 2023: Apalutamide Highlights & Side Effects. Trial Name: NCT01946204 — Phase 3
Apalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01946204 — Phase 3
~100 spots leftby Nov 2025
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