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Trial · NCT06496581

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall survival (OS)From randomization to death due to any cause, up to 8.5 yearsOverall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
PrimaryRadiographic progression-free survival (rPFS)From randomization to radiographic progression or death, up to 8.5 years
Radiographic progression-free survival (rPFS) is defined as the time from randomization to the date of radiographic progression according to PCWG3 criteria by investigator assessment, or death, whichever occurs first.
SecondaryCastration-Resistance Prostate Cancer-Free Survival (CRPC-FS)From randomization to onset of castration-resistance or death, up to 8.5 yearsCastration-Resistance Prostate Cancer-Free Survival (CRPC-FS) is defined as the time from randomization to the onset of castration-resistance or death from any cause, whichever occurs first.
SecondaryProstate Cancer-Specific Survival (PCSS)From the date of randomization to a PCSS event, up to 8.5 yearsProstate Cancer-Specific Survival (PCSS) is defined as the time from the date of randomization to the date of death due to prostate cancer.
SecondaryPSA responseFrom baseline over the treatment period, up to 8.5 yearsPSA response will be assessed by the maximum change of PSA (rise or fall) from baseline over the treatment period. A complete PSA response is defined by an undetectable level of serum PSA.
SecondarySkeletal-related event-free survival (SRE-FS)From randomization to the onset of a SRE-FS event, up to 8.5 years
Skeletal-related event-free survival (SRE-FS) is defined as the time from the randomization date to the date of diagnosis of either a skeletal-related event (SRE) (fracture, or bone pain requiring radiation therapy, or spinal cord compression, or preventive surgery to the bones) or death, whichever occurs first.
SecondaryTime to severe urinary event (SUE)From randomization to the onset of a SUE event, up to 8.5 years
Time to severe urinary event (SUE) is defined as the time from the randomization date to the date of diagnosis of either one of the following SUE, whichever occurs first: urinary retention with need for a urinary catheter, suprapubic catheter, double J stent, nephrostomy, treatment of the prostate by radiotherapy or trans-urethral resection of the prostate (TURP) or prostatectomy done to relieve patients with local symptoms.
SecondaryTime to initiation of first subsequent anti-cancer systemic therapy for CRPC (TTSST1)From randomization to initiation of the first anti-cancer systemic therapy for CRPC, up to 10 yearsTTSST1 is defined as the time from the randomization date to the date of initiation of the first anti-cancer systemic therapy for CRPC.
SecondaryTime to initiation of second subsequent anti-cancer systemic therapy for CRPC (TTSST2)From randomization to initiation of the second anti-cancer systemic therapy for CRPC, up to 10 yearsTTSST2 is defined as the time from the randomization date to the date of initiation of the second anti-cancer systemic therapy for CRPC.
SecondaryEfficacy of first subsequent anti-cancer systemic therapy for CRPCFrom first anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years
Efficacy of subsequent anti-cancer systemic therapy for CRPC will be defined as the time from first anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first.
SecondaryEfficacy of second subsequent anti-cancer systemic therapy for CRPCFromsecond anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years
Efficacy of second subsequent anti-cancer systemic therapy for CRPC will be defined as the time from second anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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