Phil

From the trial protocol...http://patch.mrcctu.ucl.ac.uk/media/1310/patch-protocol_v150_may_clean_signed-2024_.pdf

In order to be considered eligible for enrolment in this trial, patients should fulfil one of the
criteria in the first section.

Additionally, all patients must fulfil all of the criteria in the second section and none of the exclusion criteria.

Newly Diagnosed Patients
…with one of:-
(i) Stage T3/4 NO or NX M0 histologically confirmed prostate adenocarcinoma with
either PSA≥20ng/ml or Gleason sum score ≥6
(ii) Stage Tany N+ M0 or Tany Nany M+ histologically confirmed prostate adenocarcinoma
(iii) Multiple sclerotic bone metastases with a PSA≥50ng/ml without histological
confirmation of prostate cancer
OR
Patients with histologically confirmed prostate adenocarcinoma
previously treated with radical surgery and/or radiotherapy who are now relapsing …with at least one of:-
(i) PSA ≥4ng/ml and rising with doubling time less than 6 months
(ii) PSA ≥20ng/ml
(iii) Documented evidence of metastatic disease with PSA>4ng/ml

For all patients
(i) Intention to treat with continuous long-term ADT (> 3 year
(ii) Fit for all protocol treatment and follow-up, WHO performance status 0-2 (see Appendix A)
(iii) Should have completed the appropriate investigations prior to randomisation (see Section 4.4)
(iv) Written informed consent
(v) Willing and expected to comply with protocol
(vi) For newly diagnosed N0M0 patients only – Intention to treat with radical radiotherapy (unless there is a specific contraindication; exemption can be sought in advance of consent after discussion with the PATCH Trial Manager).

Note: Prior hormone therapy for localised disease must have been completed at least 12 months previously and
have been no longer than 12 months in duration. It can have been given as adjuvant or neoadjuvant therapy..

Kevin