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Antiandrogen

Apalutamide for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Tian Zhang, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery.
Evidence of disease recurrence or progression as evidenced by a PSA > 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir OR one PSA value above 0.20 ng/mL IF the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new treatment for prostate cancer that has come back after surgery. They are testing to see if it can help people live longer without the cancer progressing.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Progression-free Survival (PFS) at 36 Months (3 Years)
Secondary outcome measures
Biochemical Progression-free Survival (PFS) at 36 Months (3 Years)
Median PSA Nadir Value
Number of Participants With a PSA of <0.1 ng/mL and Testosterone Recovery at 12 Months Post-Cycle 1 Day 1
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Recurrent PSA-only non-metastatic prostate cancerExperimental Treatment4 Interventions
Subjects with recurrent PSA-only prostate cancer within 4 years of prostatectomy, and a PSA of greater than 0.2 ng/mL and less than 4 ng/mL in the absence of metastatic disease on CT and bone scans.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen deprivation
2014
Completed Phase 2
~80
Apalutamide
FDA approved
Salvage radiation therapy
2018
Completed Phase 2
~40
Docetaxel
FDA approved

Find a Location

Who is running the clinical trial?

Tian Zhang, MDLead Sponsor
Andrew J. Armstrong, MDLead Sponsor
4 Previous Clinical Trials
113 Total Patients Enrolled
3 Trials studying Prostate Cancer
70 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

To what extent is Apalutamide detrimental to one's health?

"Due to limited data supporting efficacy, Apalutamide was rated a 2 for safety."

Answered by AI

How widespread is this clinical trial's presence?

"Five separate sites are currently participating in this trial, located in Omaha, Durham, Winston-Salem and other cities. When selecting a location to participate from it is beneficial to consider the closest one for convenience of travel."

Answered by AI

Has Apalutamide been investigated in any prior clinical experiments?

"At the current time, 359 Apalutamide-related studies are ongoing globally. Of these trials, 140 have progressed to Phase 3. 24762 clinical trial sites around the world offer this medication, with a majority of them located in Fuzhou City, Fujian Province."

Answered by AI

Is this experiment still actively recruiting participants?

"At this time, recruitment for the trial is not occurring. The original posting was on March 28th 2018 and it has since been revised as of November 10th 2022. If you are looking to participate in a medical study, there are 1321 active studies related to prostate cancer and 359 concerning Apalutamide that need participants."

Answered by AI

In what diseases is Apalutamide frequently prescribed?

"Apalutamide has the potential to treat multiple neoplasms, as well as prostate cancer non-metastatic and any cases of resistance or advance directives associated with hormone therapy."

Answered by AI

What is the enrollment rate for this research endeavor?

"This experiment is no longer recruiting participants. It was first publicized on March 28th 2018 and its information was last updated on November 10th 2022. Currently, 1321 trials related to prostate cancer are enrolling patients, with 359 looking for Apalutamide candidates specifically."

Answered by AI
~6 spots leftby Mar 2025