URCC NCORP

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URCC22053 | v3.0 Study Protocol Amendment Activation

We are happy to announce that we have received approval and have activated URCC22053: High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients, v3.0

The main changes of this amendment are listed below:

  • Widened Eligibility Criteria
    • Age range changed from 60 + to 50 +
    • Vitamin D levels changed from ≤ 27 ng/mL to ≤ 32 ng/mL 
    • ADT initiation window changed from within the last 3 months, to 6 months
  • Sample Size modification, now anticipating 240 participants total
  • Removal of Blood Collections for Research Purposes
    • Safety draws (1 SST; sent to CLIA lab) is retained at all timepoints.

Reconsent is not required for this amendment.

This protocol has gone through the NCI CIRB and is supported by the NCI CTSU. The approved protocol, study assessment forms and other documents are posted on the CTSU website. Your site will need to submit your CIRB approved Study‐Specific Worksheet, Annual Principal Investigator Worksheet and your Annual Signatory Institution Worksheet to: URCC_Regulatory@URMC.Rochester.edu. 

For sites that already have CIRB approval, the changes listed in this protocol amendment need to be implemented by 09/06/2025.

For more information, please log in to view the study webpage.

Training session/webinar

We will be offering training session/webinar on 08/21/2025 (Thursday) at 2:00 PM EST.
Register Here: https://urcc-ncorp.org/sessions/7587220f56a8bac0

Please reach out to URCC_22053@urmc.rochester.edu with any questions.