STAMPEDE2 Amendment Update

The full amendment pack for Substantial Modification 07 and 08 is now available. Please access the password protected Essential Documents page of this website. The Substantial Amendment Document Pack file is located under the Regulatory/Approval Documents section of the page, under the Substantial Amendment Packs heading.

This is applicable for both Comparison P and Comparison S sites to implement

Please note it is important that your site implement these on 23rd November 2026 so you can continue to seamlessly randomise patients moving to the updated Patient Information and Informed Consent forms. Please make sure patients receive the appropriate PISs and ICFs when you site has been greenlit to the amendment and choose the correct version in OpenClinica. The new ICFs will be available on OC from Monday October 19th 2026, but only use the new version when your site has the approvals in place for this amendment and the CTU have acknowledged this. There are also updated GP letters and Patient card version 4 (printed ones will be sent to Comparison P sites in late October).

An updated PSA and Testosterone worksheet version is also available on the website version STAMPEDE2 Worksheet PSA and Testosterone v3.0 06-Aug-2026

Once the SM has been approved a list of previous arm P patients will be sent to your site with further instructions regarding how to log the discussions with each participant around the updates in the approved letter:  ¹⁷⁷Lu-PSMA-617 Participant Letter Substantial Modification 08 V2.0, 13/08/2026

Comparison	Document	Updated Version
ALL	Registration Participant Information Sheet	V8.0, 07/07/2026
ALL	Partner Pregnancy Participant Information Sheet	V7.0, 07/07/2026
S	Comparison S Participant Information Sheet	V7.0, 07/07/2026
P	Comparison P Participant Information Sheet	V10.0, 19/08/2026
ALL	STAMPEDE2 Quality of Life Sub-Study Participant Information Sheet	V3.0, 07/07/2026
ALL	Registration Informed Consent Form	V8.0, 07/07/2026
ALL	Partner Pregnancy Informed Consent Form	V7.0, 07/07/2026
S	Comparison S Informed Consent Form	V7.0, 07/07/2026
P	Comparison P Informed Consent Form	V10.0, 19/08/2026
ALL	STAMPEDE2 Quality of Life Sub-Study Informed Consent Form	V3.0, 07/07/2026
S	Comparison S GP Letter	V3.0, 07/07/2026
P	Comparison P GP Letter	V3.0, 07/07/2026
P	Comparison P Patient Card	V4.0, 26/08/2026
P	177Lu-PSMA-617 Participant Letter Substantial Modification 08	V2.0, 13/08/2026

 

An updated ISF checklist can now be found here STAMPEDE2 Trial ISF Self Assessment Form v12.0 09Oct2026 

Thank you for all your hard working.

STAMPEDE2 Team