jRCTs041240151RecruitingNot Applicable
Open-labelled single-arm phase II clinical trial of triplet therapy (ADT + DAR + biweekly DTX) for high-risk metastatic castration-sensitive prostate cancer (Open-labelled single-arm phase II clinical trial of triplet therapy (ADT + DAR + biweekly DTX) for high-risk metastatic castration-sensitive prostate cancer)
Not provided0 sites30 target enrollmentStarted: January 8, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Single Arm Study
- Intervention Model
- Single Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- Male
Inclusion Criteria
- •Metastatic castration-sensitive prostate cancer
- •Histologically adenocarcinoma
- •Age greater than or equal to 20 years
- •Performance Status (ECOG) 0-2
- •Meet the following high-risk criteria
- •Gleason pattern 5 is present.
- •BSI* 1.5 and above *BSI: bone scan index
- •LDH 300 IU/L and above
- •Meet at least two out of the following three criteria.
- •(6) The patient's free and voluntary written consent has been obtained after sufficient informed consent for participation in the clinical research.
Exclusion Criteria
- •Patients already receiving any treatment for mCSPC (with the exception of ADT or CAB in the 3 months prior to the start of this study)
- •Patients who have participated in other clinical studies (clinical trials) within 3 months prior to the start of study drug administration
- •Patients with known hypersensitivity to ADT, DAR or DTX
- •Patients with severe myelosuppression
- •Patients with concomitant infections or suspected infections
- •Patients with severe (Child-Pugh Classification C) hepatic dysfunction
- •Patients with end-stage renal failure on dialysis or with an eGFR of less than 15 mL/min/1.73 m
- •Patients who are judged to be unsuitable as research subjects by the principal investigator or a sub-investigator.
Outcomes
Primary Outcomes
-
PSA response rate
Secondary Outcomes
No secondary outcomes reported
Investigators
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