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177Lu-HTK03170 in mCRPC With PSMA Positive Disease

StatusEnrolling by Invitation
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Suspended to Enrolling by Invitation Primary completion date: Mar 1, 2026 to Dec 1, 2026v7 Show 1 more changeShow less
    • Primary completion date: Mar 1, 2026 to Dec 1, 2026
  2. Trial status: Recruiting to Suspended Sponsor's reason: The study has been temporarily suspended due to significant delays in the availability of the investigational product , resulting from… Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  3. Site contact updatedv5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 1, 2023 to Jan 1, 2024 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Oct 1, 2023 to Jan 1, 2024
    • Site details revised
  5. Start date: Mar 1, 2023 to Oct 1, 2023v3
  6. Start date: Dec 1, 2022 to Mar 1, 2023 Enrollment target: 56 to 50 · Primary completion date: Dec 1, 2026 to Mar 1, 2026 · Completion date: Dec 1, 2027 to May 1, 2027 · 2 morev2 Show 5 more changesShow less
    • Enrollment target: 56 to 50
    • Primary completion date: Dec 1, 2026 to Mar 1, 2026
    • Completion date: Dec 1, 2027 to May 1, 2027
    • Study description revised
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will determine the safe initial injected activity of the radioligand therapy 177Lu-HTK03170 for the measurement of dosimetry and initiation of treatment in subjects with PSMA-positive, metastatic castrate resistant prostate cancer, (mCRPC). Subjects will receive treatment which will be escalated between cycles and personalized based on dosimetry calculations and imaging. In addition, antitumour activity will be measured by radiographic response, and further assessments of the treatment will be measured by CT imaging, ctDNA/ctRNA, PSA, PSMA PET/CT, and quality of life questionnaires. Subjects will be followed for 2 years or until they have progression and are switched to another systemic treatment.
Trial Details
NCT Number NCT05570994
Lead Sponsor British Columbia Cancer Agency
Conditions Metastatic Castration-resistant Prostate Cancer, Prostate Cancer Metastatic, Castrate Resistant Prostate Cancer
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov