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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later May 1, 2027 → Feb 28, 2028
See other at-risk trials from Milton S. Hershey Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 1, 2027 to Feb 28, 2028
    • Study completion pushed from May 1, 2028 to Aug 31, 2028
    • Site contact updated
    v9
  2. Eligibility criteria expanded, about 121 wordsv8
  3. Primary endpoints: 4 to 5
    • Study description expanded, about 63 words
    • Site contact updated
    v7
  4. Primary endpoints revised (4)
    • Eligibility criteria expanded, about 62 words
    • Site contact updated
    v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 1, 2025 to May 7, 2025
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria shortened, about 15 wordsv4
  2. Start date: Mar 1, 2025 to May 1, 2025
    • Primary completion date: Jan 1, 2027 to May 1, 2027
    • Study completion date: Jan 1, 2028 to May 1, 2028
    • Eligibility criteria shortened, about 87 words
    v3
  3. Start date: Jan 1, 2025 to Mar 1, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06600698
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov