Trial · NCT07333066
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS) | 48 months | Event-free survival is defined as the time from randomization to occurrence of the following events, whichever occurs first in each treatment arm: PSA progression or radiographic progression of soft-tissue, visceral, or bone lesions or death from any cause. |
| Secondary | Time to castration resistance | 48 months | Time to castration resistance is defined as time from randomization to radiographic disease progression, PSA progression per PCWG3 criteria, or symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms), whichever occurred first in each treatment arm. |
| Secondary | Radiographic progression-free survival (rPFS) | 48 months | Radiographic Progression-Free Survival is defined as the time from randomization to the first documented evidence of radiographic disease progression, as assessed by the investigator per Prostate Cancer Working Group 3 (PCWG3) criteria for bone lesions and RECIST v1.1 for soft tissue lesions, or death from any cause, whichever occurs first in each treatment arm. |
| Secondary | PSA progression-free survival | 48 months | PSA progression-free survival (PSA-PFS) is defined according to PCWG3 criteria as the time from randomization to the date of PSA progression (a ≥25% increase and an absolute increase of ≥2 ng/mL from nadir, confirmed by a second value ≥3 weeks later) or death from any cause, whichever occurs first in each treatment arm. |
| Secondary | Overall survival | 48 months | Overall survival is defined as time from randomization to date of death from any cause in each treatment arm. |
| Secondary | Time to subsequent treatment | 48 months | Time to subsequent treatment is defined as the time from randomization to the initiation of the first subsequent systemic anticancer therapy after study drugs discontinuation, or death, whichever occurs first in each treatment arm. |
| Secondary | Deep PSA response rate at 6 months in each treatment arm. | 6 months | Deep PSA response is defined as achieving a prostate-specific antigen (PSA) level ≤0.2 ng/mL or PSA Response ≥90% in combination with a PSA ≤ 4 ng/ml. |
| Secondary | Ultradeep PSA response rate at 6 months in each treatment arm. | 6 months | Ultradeep PSA response 1 is defined as achieving a prostate-specific antigen (PSA) level between 0.2 and 0.02 ng/mL. Ultradeep PSA response 2 is defined as achieving a prostate-specific antigen (PSA) level ≤ 0.02 ng/mL. |
| Secondary | Symptomatic skeletal event-free survival | 48 months | Symptomatic skeletal event-free survival (SSE-FS) is defined as the time from randomization to the first occurrence of a symptomatic skeletal event (defined as radiation to bone, pathologic fracture, spinal cord compression, or surgery to bone due to symptoms) or death from any cause, whichever occurred first in each treatment arm. |
| Secondary | To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Adverse events) | 25 months | Percentage of patients with at least one adverse event. Toxicity profile will be assessed using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0. Patients with each adverse event will be calculated over the total number of patients exposed in each treatment arm. |
| Secondary | Time to initiate opioid use (≥ 7 days) | 48 months | Time to initiate opioid use (≥ 7 days) is defined as the time from randomization to the first initiation of opioid analgesic use lasting for 7 or more consecutive days, regardless of the reason, or until death, whichever occurs first in each treatment arm. |
| Secondary | To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Serious adverse events). | 25 months | Patients with at least a serious adverse event will be calculated over the total number of patients exposed in each treatment arm. |
| Secondary | To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Adverse events leading to treatment discontinuation ). | 25 months | Patients with at least an adverse event leading to treatment discontinuation and adverse events leading to death will be calculated over the total number of patients exposed in each treatment arm. |
| Secondary | To evaluate the safety profile of treatment intensification with docetaxel plus apalutamide and ADT (Death) | 25 months | Dead patients calculated over the total number of patients exposed in each treatment arm. |
| Secondary | To assess the quality of life of patients with FACT-P subscale | 24 months | Change from baseline over time in FACT-P subscale in each treatment arm. |
| Secondary | To assess the quality of life of patients with BPI-SF interference subscale | 24 months | Change from baseline over time in BPI-SF interference subscale in each treatment arm. |
| Secondary | To assess the quality of life of patients with BPI-SF interference subscale. | 24 months | Change from baseline over time in BFI subscale in each treatment arm. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07333066/registered