TRIC

JRCT ID: jRCTs041240151

Registered date:18/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Metastatic castration-sensitive prostate cancer
• Date of first enrollment: 08/01/2025
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: PSA response rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Hiroaki Iwamoto