SYF48b7d90f0eac474784c185fde2083c06Registry ID: 2024-517901-97-00|Active Not RecruitingPhase 2
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interventional
N/A
1 country
1
The primary objective is the assessment of efficacy and safety of the combination of ADT, apalutamide and stereotactic radiotherapy on the localized or locally advanced high-risk prostate cancer. Efficacy assessment is determined by the biochemical control rate after 5 years, and biochemical progression is defined according to RTOG – ASTRO Phoenix consensus criteria (a rise by 2 ng/mL or more above the nadir PSA with the date of failure determined "at call"). Safety assessment is determined by the rate of clinically significant G2 and G3 gastrointestinal and genitourinary toxicity.
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.
October 11, 2024
Actual (reported)5-year biochemical control rate defined as a percentage of surviving patients without biochemical progression after 5 years since the treatment start (assessed by Kaplan-Meier estimate).
Major secondary endpoint: Metastasis free survival based on PSMA PET/CT (assessed by Kaplan-Meier estimate).
5-year biochemical control rate with PSA <0.2 ng/mL.
5-year prostate cancer specific survival.
5-year overall survival (OS). OS is defined as the time from enrollment to date of death from any cause.
Incidence of acute and late side effects and complications associated with radiotherapy and systemic treatment evaluated by Common Terminology Criteria of Adverse Event (CTCAE) and Patient Reported Outcomes (PRO) including QoL questionnaires.
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Formulated product
JNJ-56021927
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
JNJ-56021927
Named ingredient: apalutamide
View registry recordVychodoslovensky Onkologicky Ustav a.s.
Kosice, 040 01, Slovakia
Principal Investigator
First Submitted
October 11, 2024
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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:
Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
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