A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prost… (NCT07553988) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer
Russia120 participantsStarted 2024-10-24
Plain-language summary
The primary objective of the study is to determine the therapeutic dose of RS-113 in patients with metastatic castration-resistant prostate cancer based on efficacy, safety, and pharmacokinetic parameters. The secondary objectives are to assess a pilot efficacy and safety of different doses of RS-113 versus abiraterone, as well as to investigate pharmacokinetics profile and to perform a pilot evaluation of pharmacokinetics parameters of RS-113 in patients with metastatic castration-resistant prostate cancer
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Voluntarily signed and dated Informed Consent Form (ICF) of the patient agreed to take part in this Study
✓. Histologically confirmed diagnosis of prostate adenocarcinoma showing no neuroendocrine, signet-ring cell, small cell, or ductal differentiation
✓. Ongoing androgen deprivation therapy for prostate cancer aimed at testosterone suppression with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule for at least 4 weeks immediately prior to Day 1, or a history of bilateral orchiectomy (i.e., medical or surgical castration). Patients who have not undergone bilateral orchiectomy must agree to continue effective continuous LHRH analogue therapy throughout the study
✓. Evidence of progressive disease at the time of randomization, defined by one or more of the following criteria:
✓. Disease progression occurring during androgen deprivation therapy or during or after docetaxel chemotherapy administered as first-line treatment for metastatic hormone-sensitive prostate cancer
✓. Asymptomatic or mildly symptomatic prostate cancer, defined as a score \< 4 on Question 3 of the Brief Pain Inventory-Short Form (BPI-SF)
Exclusion criteria
✕. Presence of central nervous system (CNS) metastases that are progressive or associated with clinical symptoms (e.g., cerebral edema, spinal cord compression), or requiring treatment with glucocorticoids and/or anticonvulsants. Patients with brain metastases may be enrolled in case adequate treatment (surgery and/or radiotherapy) has been completed and radiographic stability has been documented for at least 4 weeks prior to the planned date of randomization. Newly diagnosed CNS metastases identified during screening that are asymptomatic and do not require treatment are not considered an exclusion criterion
What they're measuring
1
Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms
✕. Presence of untreated spinal cord compression or any other severe or systemic disease increasing the risk of treatment-related complications
✕. Presence of clinically significant pituitary or adrenal dysfunction that cannot be adequately controlled with stable-dose hormonal or other standard therapy for at least 28 days prior to the planned date of randomization
✕. History of another malignancy that is progressive or required anticancer treatment (including hormonal therapy) within 5 years prior to the planned date of randomization, except curatively treated basal cell or squamous cell carcinoma of the skin
✕. History of other significant comorbid conditions that, in the investigator's opinion, may worsen during the study, including uncontrolled diabetes mellitus