COMPARE study

JRCT ID: jRCTs031220430

Registered date:01/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostatic Neoplasms
• Date of first enrollment: 16/02/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Apalutamide and targeted radiotherapy

Outcome(s)

• Primary Outcome: ADT-free PSA progression-free survival

Secondary Outcome

Undetectable PSA rate
Radiographic response in lesions treated with SBRT or IMRT
ADT-free radiographic progression-free survival
CSS, OS
Change in QOL

Key inclusion & exclusion criteria

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

Include criteria

Include patients that meet all of the following criteria:.
(1)Patients aged 20 years or older who can obtain informed consent
(2)Patients with histologically or cytologically confirmed prostate cancer without neuroendocrine carcinoma, signet-ring cell carcinoma, or small cell carcinoma morphology
(3)Patients who did not receive androgen deprivation therapy with GnRH agonists/antagonists, first-generation antiandrogens (bicalutamide, flutamide, prostar, etc.) or bilateral orchiectomy, or who were initiated these therapies within 6 months prior to study entry
(4)Patients with 1 - 3 bone, organ, or lymph node metastases detected by routine CT, MRI, or bone scintigraphy within 3 months
(5)Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
(6)Patients who are expected to live at least 2 years
(7)Patients who can comply with study protocol visits and other procedures

Exclude criteria

Patients who meet any of the following criteria are not included in this study:
(1)Patients who have been treated with androgen deprivation therapy to treat prostate cancer (abiraterone acetate, apalutamide, enzalutamide, darolutamide), androgen receptor targeting agents, cytotoxic chemotherapy, ketoconazole, or olaparib
(2)Patients who used the study drug within 4 weeks of the study start date
(3)Patients with a history of invasive cancer other than prostate cancer within 3 years of study entry
(4)Patients with neutrophil count < 1,000/microliter, platelet count < 100,000/microliter, and hemoglobin < 10 g/dL at screening
(5)Patients with total bilirubin >= 1.5 times the upper limit of normal (ULN) and ALT and AST >= 2.5 times the ULN at screening
(6)Patients with creatinine levels > 2 mg/dL at screening
(7)Patients with albumin < 3.0 g/dL at screening
(8)Patients with a history of convulsive seizures or conditions that predispose to convulsive seizures
(9)Patients with clinically significant cardiovascular disease
(10)Patients with GI disorders affecting absorption
(11)Patients who underwent major surgery under general anesthesia within 4 weeks of study initiation
(12)Patients with a history of hypersensitivity to any of the ingredients of this product
(13)Patients with conditions that place the patient at undue risk, interfere with the completion of the study, or interfere with the analysis of the study results
(14)Patients with a past history of radiation therapy at the target for metastatic-directed therapy

Related Information

• Primary Sponsor: Kijima Toshiki
• Source(s) of Monetary Support: Janssen Pharmaceutical K.K.