PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)

Prostate cancer

Progression-free survival (PFS), defined as time from initiation of RT to - biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] - appearance of metastases or loco-regional recurrence as defined below - death from any cause whichever occurs first

Change in initial treatment intent, Metastasis-free survival (MFS), defined as time from initiation of RT to occurrence of new metastases defined as - PET or radiographic bone or soft tissue distant metastases by blinded independent central review* - pathologic finding of distant metastases - death from any cause whichever occurs first, Loco-regional control (pelvis) Occurrence of loco-regional progression defined as (whichever occurs first): - PET or radiographic pelvic non-bone PCa lesions by blinded independent central review* - Pathologic finding of pelvic non-bone PCa lesions, Overall survival (OS), defined as time from initiation of RT to death from any cause., Post-salvage bPFS - In patients without salvage therapy: Time from initiation of RT until progression as defined above (primary endpoint) - In patients with salvage therapy: Time from initiation of RT until progression post-salvage therapy as defined above (primary endpoint) *Following the joint EAU ESUR ESTRO SIOG 2018 guideline, Section 6.3.4.4, Safety endpoints: Adverse events of CTC grade ≥3 and serious adverse events (SAE) according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, v5.0, 2017).

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