SYFaaa1c33ac8364172baa9da09c5f070c9Registry ID: 2023-506032-33-00|Not Yet RecruitingPhase 3
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interventional
N/A
1 country
1
To assess difference in efficacy between curative-intent RT based on PSMA PET vs based on standard-of care imaging, in patients with primary prostate cancer (intermediate- or high-risk) for whom curative-intent RT is appropriate given the imaging results.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2025
Actual (reported)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
Universitaetsklinikum Essen AöR
Essen, 45147, Germany
Studienzentrum GmbH
First Submitted
April 16, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
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