MEtastasis-Directed therapy with Alpha emitter Radium-223 for Oligometastatic Castration-resistant prostate cancer

JRCT ID: jRCTs031200358

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostatic Neoplasms, Castration-Resistant
• Date of first enrollment: 29/03/2021
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Radium-223

Outcome(s)

• Primary Outcome: Progression-free survival from randomization to progression of bone metastases on whole body-DWI (central judgment).

Secondary Outcome

1, Progression-free survival from randomization to appearance of new bone metastases outside the field of targeted therapy on whole body-DWI (central judgment)
2, Progression-free survival from randomization to exacerbation of bone metastases on whole body-DWI (each investigators judgment)
3, Progression-free survival from randomization to the appearance of new bone metastases outside the field of targeted therapy on whole body-DWI (each investigators judgment)
4, Overall survival
5, Time to PSA and total ALP progression
6, Change in PSA and total ALP
7, Time to initiation of subsequent systemic anticancer therapy
8, Change in QOL

Key inclusion & exclusion criteria

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

Include criteria

Patients with all of the following conditions will be eligible
(1) Histologically or cytologically confirmed prostate cancer.
(2) Those with known castration resistance as defined below
a, Serum testosterone equal or less than 50 ng/dL (1.7 nmol/L)
b, Bilateral vasectomy or maintenance of luteinizing hormone releasing hormone (LHRH) agonists or LHRH antagonists or androgen deprivation therapy during the study period.
c, Prostate Specific Antigen (PSA) exacerbation (two consecutive increases in PSA from the historical baseline at intervals of at least one week) or (an increase of at least 1 ng/dL above the lowest PSA level)
d, The appearance of new lesions or worsening of the disease by imaging studies.
(3) Active metastases confined to one to three bone sites on whole-body diffusion-weighted magnetic resonance imaging (WB-DWI) within the past three months.
(4) 20 years and older
(5) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0-2.
(6) Those that meet the following criteria of clinical laboratory standards
a, Absolute neutrophil count equal or greater than 1.5 x 1,000,000/L
b, Platelet count equal or greater than 100 x 1000,000,000/L
c, Hemoglobin equal or greater than 10.0 g/dL (6.2 nmol/L)
d, Total bilirubin equal or less than 1.5 times the upper limit of the institutional reference value (ULN)
e, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) equal or less than 2.5 times the ULN.
f, Creatinine equal or less 1.5 times higher than ULN
g, Absolute neutrophil count equal or greater than 1.5 x 1,000,000/L
h, Albumin equal or greater than 25 g/L
i, Corrected calcium equal or greater than 8.4 mg/dL
(7) Willing and able to follow the study protocol, including follow-up visits and examinations.
(8) Have received sufficient information about the study and have signed a consent form.

Exclude criteria

A person is ineligible if he meets any of the following criteria.
(1) Receiving another research drug within the past 4 weeks or planning to receive another research drug during the period of research drug administration.
(2) Patients who have received cytotoxic chemotherapy within the past three weeks, are scheduled to receive the study drug, or have not recovered from an adverse event caused by cytotoxic chemotherapy administered prior to four weeks (but ongoing neuropathy was allowed)
(3) Those who have undergone semi-body irradiation
(4) Received systemic administration of radioactive isotopes of Yttrium-90, Lutetium-177, Bismuth-213, Strontium-89, Samarium-153, Rhenium-186, and Rhenium-188 for treatment of bone metastases within the past 24 weeks.
(5) Those treated with radium chloride (223Ra)
(6) Received blood transfusion or erythropoietin within the past four weeks.
(7) Whole body diffusion-weighted MRI within the past 3 months with organ or lymph node metastases or active lesions in the prostate.
(8) Clinical findings or those with imminent or obvious spinal cord compression by MRI
(9) Have any other serious illness or medical condition that is listed below (but not limited to)
a, poorly controled infections
b, Class III or IV heart failure according to the New York Heart Association classification of heart funciton
c, Crohn's disease or ulcerative colitis
d, Myelodysplastic syndrome
(10) Fecal incontinence that is difficult to manage
(11) Patients who are judged to require the use of olaparib, new hormonal agents including enzalutamide, and abiraterone acetate and prednisolone or chemotherapy while receiving the study drug
(12) Patients with a history of prior irradiation of the intended target therapy site.
(13) Patients with visceral metastases diagnosed in the past

Related Information

• Primary Sponsor: Yoshida Soichiro
• Secondary Sponsor: Fujii Yasuhisa
• Source(s) of Monetary Support: Bayer Pharmaceuticals