Trial · NCT05383079
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting toxicities (DLTs) | Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited. | A DLT is defined as a toxicity that prevents further administration of the trial treatment at that dose level. Each cohort of 3 patients be assessed for DLTs in the first 6 weeks (cycle 1) of treatment and a dose for the next cohort will be determined. |
| Primary | Maximum Tolerated dose (MTD) | Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited. | The MTD is defined as the highest dose level at which the incidence of DLT was less than 2/6. |
| Primary | Recommended Phase 2 Dose (RP2D) | Up to 30 months from the time the first patient is recruited. | After the MTD is established, additional patients will be treated at the MTD. Safety and efficacy data from the study will be used to define the RP2D. |
| Primary | 50% Prostate-Specific Antigen Response Rate (PSA-RR) | Through study completion, up until 12 months after the last patient commences treatment | PSA will be assessed at baseline and every 3 weeks from cycle 1 day 1. PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. |
| Secondary | Adverse Events and Serious Adverse Events measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | Through study completion, up until 12 months after the last patient commences treatment | Safety of the combination will be measured by AEs and SAEs. |
| Secondary | Radiographic Progression-Free Survival (rPFS) | Through study completion, up until 12 months after the last patient commences treatment | rPFS is defined as the time from treatment initiation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first. The radiographic progression will be assessed by the investigator per RECIST1.1 for soft tissue and PCWG3 for bone lesions. |
| Secondary | PSA progression free survival (PSA-PFS) | Through study completion, up until 12 months after the last patient commences treatment | PSA-PFS is defined as the time from treatment initiation to the date of PSA progression per PCWG3 or death due to any cause, whichever occurs first. The date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2ng/mL or more from the nadir is documented. For patients who have an initial PSA decline during treatment, this must be confirmed by a second value 3 or more weeks later. |
| Secondary | Overall survival (OS) | Through study completion, up until 12 months after the last patient commences treatment | OS is defined as the time from treatment initiation to the date of death due to any cause. |
| Secondary | Objective response rate (ORR) by RECIST1.1 in patients with measurable disease | Through study completion, up until 12 months after the last patient commences treatment | Objective Response (OR) is only applicable for the subset of patients with measurable disease by RECIST1.1. OR is defined as a partial response (PR) or complete response (CR) at any stage from time of commencement of protocol treatment to the time of subsequent systemic anti-cancer treatment. The ORR is calculated as the proportion of patients with a best response of CR or PR. |
| Secondary | Progression Free Survival (PFS) | Through study completion, up until 12 months after the last patient commences treatment | Time from randomisation to the date of PSA progression, or radiographic progression (PCWG3 for bone and RECIST 1.1 for soft tissue), or death. |
| Secondary | Describe pain within 12 months of treatment commencement | Through completion of 12 months after treatment commencement of last patient | Pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF). The primary endpoint for pain is the area under the curve (AUC) of the worst pain in 24h. Pain and QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals. |
| Secondary | Describe health-related QoL within 12 months of treatment commencement | Through completion of 12 months after treatment commencement of last patient | QoL will be assessed using the Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) questionnaire. The primary endpoint for QoL is the area under the curve (AUC) of the trial outcome index (TOI). QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals. |
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/NCT05383079/registered