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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 43 months

Awards & highlights

SPARTAN 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.Check my eligibility

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.See study design

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.

SPARTAN Trial 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.

SPARTAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 43 months

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

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

Primary outcome measures

Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)

Secondary outcome measures

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%

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)

SPARTAN 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

~3310

0 / 4Eligibility criteria met

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

Frequently Asked Questions

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

When was Apalutamide cleared by the FDA?

"Apalutamide has been studied in multiple Phase 3 trials, so there is some evidence of efficacy and multiple rounds of data supporting safety. Our team at Power gives it a score of 3 for safety."

Answered by AI

How many individuals are being treated with this medication?

"As of right now, this particular study is not looking for any more patients. This trial was first posted on October 14th, 2013 but was edited as recently as October 25th, 2022. There are 1274 other trials for prostate cancer and 46 trials for Apalutamide that are currently seeking patients."

Answered by AI

Is this clinical trial taking place in more than one location within the city limits?

"Presently, this trial is being conducted at 100 hospitals, with additional locations in Orange, Chandler, and Fort Sam Houston. To make the process more convenient for patients, it is recommended to select a trial site nearest you."

Answered by AI

Is this the first time that Apalutamide has been studied?

"The first clinical trial for apalutamide was completed in 2013 at NCT01946204. Since then, 18257 additional trials have been completed. As of now, there are 46 active trials, a sizeable portion of which are based in Orange, California."

Answered by AI

Are there any subjects currently needed for this research?

"This study is not presently looking for patients that fit the criteria. The 10/14/2013 post date and 10/25/2022 update date can be found on the clinical trial site. There are 1274 trials for prostate cancer and 46 studies for Apalutamide that are actively recruiting patients."

Answered by AI

Is this research the first of its kind?

"Apalutamide has been under research since 2013, when the first clinical trial was conducted. The original trial was sponsored by Aragon Pharmaceuticals, Inc. and featured 1207 participants. After the first Phase 3 drug trial in 2013, Apalutamide received approval. At the moment, there are 46 active trials being conducted in 580 cities and 40 nations."

Answered by AI