Study on the Safety and Effectiveness of AGN-INM176 for Prostate Cancer Patients with Rising PSA Levels

Sponsor: Milton S. Hershey Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06600698

Provider View

This clinical trial is testing a herbal supplement called INM176 to see if it is safe and can help stabilize or lower PSA levels in men with a history of prostate cancer or those under active surveillance for low-risk disease. The study will also determine the best dose for future research.

Patient Parameters

Program Overview

The study is designed to test the safety and effectiveness of the herbal supplement INM176 in men with a history of prostate cancer or those under active surveillance for low-risk disease. The first part of the study will find the best dose of INM176 by gradually increasing the dose and checking for any side effects. The second part will test if INM176 can help stabilize or lower PSA levels in men who have had surgery or radiation therapy for prostate cancer and are experiencing rising PSA levels. Researchers will also study how the body processes the supplement and its effects on the immune system and other health markers.

Description

This study is divided into two phases. In Phase I, researchers will determine the safest and most effective dose of the herbal supplement INM176 by gradually increasing the dose and monitoring for any side effects over a 4-week period. This phase will include men with a history of prostate cancer or those under active surveillance for low-risk disease.

In Phase II, the study will evaluate if INM176 can stabilize or reduce PSA levels in men who have undergone surgery or radiation therapy for prostate cancer and are experiencing rising PSA levels. Participants will receive the supplement for six cycles, and researchers will monitor changes in PSA levels, immune system activity, and other health markers.

The study will also analyze how the body processes INM176 and its effects on the immune system, which will help design future large-scale studies to test the supplement's effectiveness in preventing prostate cancer recurrence.

Eligibility Criteria

Inclusion Criteria

  • Men aged 40 years or older.
  • Have a history of prostate cancer or are under active surveillance for low-risk prostate cancer.
  • Have completed any previous prostate cancer treatments, such as surgery or radiation therapy.
  • Not currently receiving radiation therapy or hormone therapy.
  • Have good overall health, with normal liver, kidney, and bone marrow function.
  • Agree to use two forms of birth control during the study and for one week after the last dose of the study drug.
  • Willing to stop taking any herbal supplements containing AGN extract at least 4 weeks before starting the study drug.
  • Not taking any medications that strongly interact with the study drug, unless approved by the study doctor.
  • For Phase II, must have a confirmed diagnosis of prostate adenocarcinoma and rising PSA levels over two tests within the past 6 months.

Exclusion Criteria

  • Have cancer that has spread to distant parts of the body.
  • Currently receiving treatments like chemotherapy, hormone therapy, or immunotherapy.
  • Have any uncontrolled health conditions, such as severe heart problems, uncontrolled diabetes, or active infections.
  • Have a history of severe heart failure or recent heart attack.
  • Have another active cancer that requires treatment.
  • Have severe kidney disease.
  • Taking blood thinners like Warfarin.

Locations

FACILITYZIPCITYSTATE
Penn State Cancer Institute17033HersheyPennsylvania

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