Actively Recruiting

Phase 1
Phase 2
Age: 40Years +
MALE
NCT06600698

Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA

Led by Milton S. Hershey Medical Center · Updated on 2026-04-23

45

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This Phase I/II open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.

CONDITIONS

Official Title

Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 40 years or older
  • Willing and able to give informed consent and comply with study procedures
  • History of prostate cancer diagnosis or low-risk prostate cancer under active surveillance
  • Prior prostate cancer treatments allowed include surgery, radiation therapy, and antiandrogen therapy
  • Not undergoing concurrent radiation therapy or androgen deprivation therapy at enrollment
  • ECOG performance status between 0 and 2
  • Normal liver, kidney, and bone marrow function at baseline
  • Agree to use two medically accepted methods of contraception during and shortly after the trial
  • Discontinue any herbal supplements containing Angelica Gigas Nakai extract at least 4 weeks before starting treatment
  • For Phase II: Histologically confirmed prostate adenocarcinoma with rising PSA over two tests in the past 6 months
  • No distant metastases confirmed by imaging within 5 years prior to enrollment
  • Non-castrate testosterone levels (>50 ng/dL) if prior androgen deprivation therapy history
  • No active secondary malignancy requiring treatment
  • Prior Phase I subjects must meet safety and washout criteria before Phase II enrollment
Not Eligible

You will not qualify if you...

  • Presence of distant metastatic cancer; node-positive allowed only after treatment completion
  • Currently receiving systemic chemotherapy, androgen deprivation therapy, antiandrogens, immunotherapy, or investigational agents
  • Uncontrolled intercurrent illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, uncontrolled diabetes (HbA1C >9), uncontrolled asthma, or significant psychiatric illness
  • History of severe heart failure (NYHA Class III or IV), recent myocardial infarction within 6 months, or other cardiac contraindications
  • Active secondary malignancy requiring treatment
  • Chronic kidney disease with GFR less than 30 mL/min/1.73 m2
  • Taking Warfarin or coumadin anticoagulants

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Penn State Cancer Institute

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

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Research Team

C

Crystal Sowers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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