Prostatic Neoplasms
Conditions
Interventions
Sponsors
Kijima Toshiki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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. Patients who have received temporary androgen deprivation therapy as a neoadjuvant therapy prior to radical prostatectomy or radiation therapy for localized prostate cancer are eligible for enrollment. (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
Exclusion criteria
Exclusion 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. Patients who have received temporary androgen deprivation therapy as a neoadjuvant therapy prior to radical prostatectomy or radiation therapy for localized prostate cancer are eligible for enrollment. (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 = 1.5 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADT-free PSA progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Undetectable PSA rate Radiographic response in lesions treated with SBRT or IMRT ADT-free radiographic progression-free survival CSS, OS Change in QOL | — |
Contacts
Public ContactToshiki Kijima
Dokkyo Medical University
Outcome results
None listed