Trial · NCT05658003
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic progression free survival (rPFS) | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Radiographic progression free survival (rPFS) is defined as the time of radiographic progression by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST V1.1 as assessed by blinded independent central review, or death. |
| Secondary | Overall survival (OS) | From date of randomization until date of death from any cause, assessed up to 47 months (estimated final analysis) | Overall survival (OS) is defined as the time from the date of enrollment to the date of death due to any cause. If a participant is not known to have died, then OS will be censored at the latest date the participant was known to be alive (on or before the cut-off date). |
| Secondary | Progression Free Survival (PFS) | From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first documented progression by investigator assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first. |
| Secondary | Prostate-specific antigen 50 response rate | Week 12, Week 24, Week 48 | PSA 50 response rate is the proportion of PSA responders, defined as a participant who has achieved PSA decrease of \>= 50% from baseline that is confirmed by a second consecutive PSA measurement \>= 4 weeks later. Determination of response status will be based on PCWG3 recommendations. |
| Secondary | Time to a first symptomatic skeletal event (TTSSE) | From date of randomization till date of death from any cause, whichever happens first, assessed up to 47 months (estimated final analysis) | Time to a first symptomatic skeletal event (TTSSE) is defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first. |
| Secondary | Time to Prostate Specific Antigen (PSA) progression | From date of randomization till date of Prostate Specific Antigen (PSA) progression, assessed up to 47 months (estimated analysis) | Time to PSA Progression (TTPSAP) defined as time from randomization to PSA progression. PSA progression date is defined as the date of 1) \>= 25% increase and \>= 2 ng/mL above the nadir, confirmed by a second value \>= 3 weeks later if there is a PSA decline from baseline, or 2) \>= 25% increase and \>= 2ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline: |
| Secondary | Time to chemotherapy (TTCT) | From date of randomization until date of subsequent chemotherapy or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Time to chemotherapy (TTCT) defined as time from randomization to initiation of the first subsequent chemotherapy or death, whichever occurs first. |
| Secondary | Overall response rate (ORR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Overall response rate (ORR)is defined as the proportion of participants with best overall response of complete response or partial response in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1 |
| Secondary | Disease control rate (DCR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Disease control rate (DCR) is defined as the proportion of participants with best overall response of complete response or partial response or Stable disease in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1 |
| Secondary | Time to response (TTR) | From date of randomization till 30 day safety follow-up or end of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | Time to response (TTR) is defined as the time from the date of randomization to the date of first documented response (CR or PR, which must be confirmed subsequently). CR and PR are based on tumor response data as per BICR and according to PCWG3-modified RECIST v1.1. Participants who did not achieve a confirmed CR or PR will be censored at the last adequate tumor assessment date when they did not have a PFS event or at maximum follow-up (i.e. FPFV to LPLV used for the analysis) when they did have a PFS event. |
| Secondary | Duration of response (DOR) | From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 47 months (estimated final analysis) | Duration of response (DOR) is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue as per BIRC and according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause. |
| Secondary | Time to soft tissue progression (TTSTP) | From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to 47 months (estimated final analysis) | Time to soft tissue progression (TTSTP) defined as time from randomization to radiographic soft tissue progression per PCWG3-modified RECIST v1.1 assessed by BICR. |
| Secondary | European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L) | From randomization up till 30 day safety follow-up or at LTFU2 (168 days after EOT) and LTFU4 (336 days after EOT) of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. |
| Secondary | Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire | From randomization up till 30 day safety follow-up or at LTFU2 (168 days after EOT) and LTFU4 (336 days after EOT) of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life. |
| Secondary | Brief Pain Inventory - Short Form (BPI-SF) Questionnaire | From randomization up till 30 day safety follow-up or at LTFU2 (168 days after EOT) and LTFU4 (336 days after EOT) of long term FU for patients prematurely discontinued, assessed up to 47 months (estimated final analysis) | The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use. |
| Secondary | Number of Participants with Treatment Emergent Adverse Events | From date of randomization till 30 days safety fup, assessed up to 47 months (estimated final analysis) | The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters. |
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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