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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)

TRIC (TRIC)

Hiroaki Iwamoto

Kanazawa University Hospital

13-1 Takaramachi, Kanazawa, Ishikawa

urology@med.kanazawa-u.ac.jp

Hiroaki Iwamoto

Kanazawa University Hospital

13-1 Takaramachi, Kanazawa, Ishikawa

+81-76-265-2393

urology@med.kanazawa-u.ac.jp

Recruiting

Dec. 18, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Metastatic castration-sensitive prostate cancer
2) Histologically adenocarcinoma
3) Age greater than or equal to 20 years
4) Performance Status (ECOG) 0-2
5) 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.

1) 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)
2) Patients who have participated in other clinical studies (clinical trials) within 3 months prior to the start of study drug administration
3) Patients with known hypersensitivity to ADT, DAR or DTX
4) Patients with severe myelosuppression
5) Patients with concomitant infections or suspected infections
6) Patients with severe (Child-Pugh Classification C) hepatic dysfunction
7) Patients with end-stage renal failure on dialysis or with an eGFR of less than 15 mL/min/1.73 m2.
8) Patients who are judged to be unsuitable as research subjects by the principal investigator or a sub-investigator.

Male

Metastatic castration-sensitive prostate cancer

To evaluate the effectiveness and safety, etc., of patients with high-risk metastatic castration-sensitive prostate cancer treated with androgen deprivation therapy (ADT) plus dallortamide plus docetaxel (DTX) at a dose reduced to 35 mg/m2 every two weeks for nine cycles.

metastatic castration-sensitive prostate cancer

D011471

PSA response rate

Overall survival (OS), Time to castration resistance (TTCR), Radiographic progression-free survival (rPFS), Progression free survival (PFS), Undetectable PSA rate, Time to neuroendocrine prostate cancer (NEPC), Time to double negative prostate cancer (DNPC), Symptomatic skeletal event (SSE) -free survival, Time to first SSE, Time to pain progression, Time to subsequent antineoplastic therapy, Time to cabazitaxel (CBZ), Time to performance status progression, Time until opioid use is more than 7 days, Safety, Adverse event

+81-76-265-2048

Dec. 12, 2024

none