Study on Low Dose Apalutamide's Effects on PSA Levels in Men Undergoing Prostate Surgery

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04530552

Provider View

This clinical trial is exploring whether a low dose of the drug apalutamide can lower PSA levels in men with prostate cancer who are scheduled for prostate removal surgery. The study aims to see if this approach could be useful for men with localized prostate cancer who want to delay surgery or radiation.

Patient Parameters

Program Overview

The purpose of this study is to find out if taking a low dose of apalutamide, a medication that blocks testosterone, can reduce PSA levels in men with prostate cancer that is confined to the prostate gland. Participants will take the medication for 3 to 4 weeks before their scheduled prostate surgery. If successful, this approach might be further studied for men who wish to delay more invasive treatments like surgery or radiation.

Description

The main goal of this study is to see how low doses of apalutamide affect PSA levels, which is a marker of prostate cancer activity. Researchers will also look at how the drug affects testosterone levels after stopping the medication, the concentration of the drug in the blood, and the participants' quality of life.

Participants will take apalutamide by mouth and have blood samples collected throughout the study. After finishing the treatment, they will have follow-up visits at 7-10 days, 60 days, and 3 months after their prostate surgery to monitor their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer that is confined to the prostate and suitable for surgery.
  • Gleason score of 4+4 or lower, with no pattern 5.
  • PSA level of 20 ng/ml or lower.
  • Age over 18 years.
  • General health status of 70% or higher on the Karnofsky scale.
  • Sufficient blood cell counts and organ function as determined by specific blood tests.
  • Willing to use effective birth control during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Previous or ongoing hormonal treatment for prostate cancer, except for stable doses of certain medications like finasteride or dutasteride.
  • Prostate cancer that has spread to other parts of the body.
  • Presence of certain types of cancer cells in the prostate.
  • Low testosterone levels.
  • History of other cancers within the past 2 years, except for non-melanoma skin cancer.
  • Recent severe heart problems or blood clots.
  • History of seizures or conditions that increase seizure risk.
  • Use of medications that lower the seizure threshold or interact with apalutamide.
  • Participation in other clinical trials or investigational treatments.
  • Allergies to similar medications.
  • Uncontrolled medical conditions that could make the study unsafe.

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