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Metastatic Castration-resistant Prostate CancerPhase 2NCT07553988

A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer

A Phase 2 study testing RS-113, 160 mg, RS-113, 240 mg and RS-113, 320 mg in people with Metastatic Castration-resistant Prostate Cancer, run by R-Pharm International, LLC at 16 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
RS-113, 160 mg, RS-113, 240 mg and RS-113, 320 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
16 sitesRussia
Study dates
24 Oct 2024to 9 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L)
  • Prostate-specific antigen (PSA) level > 2 ng/mL
  • Evidence of progressive disease at the time of randomization, defined by one or more of the following criteria:
Show all 21Show fewer
  • PSA progression, defined as at least two consecutive increases in PSA levels occurring ≥ 2 weeks apart, with at least one increase documented during screening; the PSA level at screening must be ≥ 2 ng/mL
  • Soft tissue disease progression based on computed tomography (CT) or magnetic resonance imaging (MRI) assessment per RECIST v1.1
  • Bone disease progression based on bone scintigraphy findings
  • 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)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥ 24 weeks
  • Major organ function must meet the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3 (1.5 × 10^9 cells/L)
  • Platelet count ≥ 100,000/mm^3 (100 × 10^9 cells/L)
  • Hemoglobin ≥ 90 g/L
  • Total bilirubin ≤ 1.5 × ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN, or ≤ 3 × ULN in the presence of liver metastases
  • Serum creatinine < 1.5 × ULN or estimated glomerular filtration rate (eGFR) > 45 mL/min, calculated using CKD-EPI equations
  • Fertile male patients must agree to abstain from heterosexual intercourse or to use highly effective methods of contraception, starting from the date of signing the informed consent form, throughout the entire study treatment period, and for at least 28 days after investigational product/comparator discontinuation

Who cannot join

  • 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
  • Prior antitumor therapy:
  • Radiotherapy (except palliative irradiation of bone lesions for pain control) within 4 weeks prior to the planned date of randomization
  • Prior treatment with first-generation antiandrogens (flutamide, bicalutamide, nilutamide) within 4 weeks prior to the planned date of randomization
  • Prior treatment with second-generation antiandrogens (enzalutamide, apalutamide, darolutamide)
  • Use of bisphosphonates or denosumab is permitted only if treatment was initiated prior to the planned date of randomization
Show all 40Show fewer
  • Clinically significant cardiovascular disease, including:
  • Myocardial infarction within 6 months prior to the planned date of randomization
  • Unstable angina within 3 months prior to the planned date of randomization
  • Chronic heart failure NYHA class III or IV
  • Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation)
  • QTc interval > 460 ms on ECG (calculated using Fridericia formula), or long QT syndrome identified at screening
  • Left ventricular ejection fraction ≤ 50% by echocardiography
  • Hypotension (systolic blood pressure < 80 mmHg) or bradycardia (heart rate < 50 bpm), except when drug-induced (e.g., beta-blockers), at the time of the planned randomization
  • Uncontrolled arterial hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg) at the time of the planned randomization
  • Clinically significant CNS disorders, including:
  • History of seizures or conditions that may predispose to seizure development
  • Presence of stroke or transient ischemic attack within 12 months prior to the planned date of randomization
  • Primary brain tumors, cerebral arteriovenous malformations, meningiomas, schwannomas, or other benign CNS disorders that may require surgical or radiation treatment (patients with such conditions may be enrolled if no surgical or radiotherapy intervention is required)
  • Traumatic brain injury or loss of consciousness within 12 months prior to the planned date of randomization
  • 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
  • Prior or concomitant therapy:
  • Use of medications that may induce seizures within 4 weeks prior to the planned date of randomization
  • Use of inhibitors or inducers of CYP3A4 or CYP2D6 within 4 weeks prior to the planned date of randomization
  • Use of medications classified as QT prolongation risk class I within 4 weeks prior to the planned date of randomization; QT risk class II medications are permitted if administered at a stable dose for at least 5 half-lives prior to the planned date of randomization
  • Prior or concomitant treatment with 5-alpha reductase inhibitors or anabolic steroids within 6 months prior to the planned date of randomization
  • Prior systemic glucocorticosteroid therapy at doses equivalent to ≥ 10 mg prednisone within 3 months prior to the planned date of randomization, except corticosteroids administered following brain irradiation, if treatment has been completed prior to enrollment in the study
  • History of allergic reactions, including reactions to medicinal products or food, that are clinically significant, in the opinion of the investigator
  • Presence of conditions limiting the patient's ability to comply with protocol requirements, including dementia, neurological or psychiatric disorders, substance or alcohol abuse, or religious or personal beliefs potentially limiting standard treatment during the study. Patients receiving narcotic analgesics for pain control may be enrolled.
  • Concurrent participation in another interventional clinical trial within 30 days prior to signing the informed consent form (if at least one dose of investigational product/comparator was received), or prior participation in this study (if at least one capsule of RS-113 or one tablet of abiraterone was administered by the patient)
  • Acute infectious diseases or exacerbation of chronic infections within 14 days prior to the planned date of randomization
  • Presence of current hepatitis B or C infection, evidence of HIV infection or active syphilis
  • Use of live vaccines within 30 days prior to the planned date of randomization. For patients receiving approved SARS-CoV-2 vaccines, the instructions for use and/or local requirements must be followed. Use of the Sputnik V vaccine is permitted provided that at least 7 days have elapsed between administration of the second vaccine dose and the first dose of the investigational product
  • Inability to swallow the investigational or comparator product
  • Inability to administer intravenous contrast
  • Presence of hypersensitivity (grade ≥ 3) to any component of RS-113, abiraterone, prednisone, or LHRH agonists (goserelin, leuprorelin, triptorelin, buserelin)
  • Presence of any other significant concomitant disease or condition that, in the investigator's reasonable judgment, may adversely affect the patient's participation, safety, or interpretation of study results

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Russia16 sites

  • State Budgetary Healthcare Institution of the Arkhangelsk Region "Arkhangelsk Oncology Dispensary"

    Arkhangelsk, 163045

  • Moscow City Clinical Oncology Hospital No. 62 of the Moscow Department of Healthcare

    Istra, 143515

  • Ivanovo Regional Oncology Dispensary

    Ivanovo, 153040

  • Kaluga Regional Clinical Oncology Dispensary

    Kaluga, 248007

  • State Budgetary Healthcare Institution "Leningrad Regional Clinical Hospital"

    Kuz'molovskiy, 191104

  • Oncology Center No. 1 of the City Clinical Hospital named after S.S. Yudin of the Moscow Healthcare Department

    Moscow, 117152

  • National Medical Research Radiological Centre of the Ministry of Health of the Russian Federation

    Moscow, 125284

  • Federal State Autonomous Institution "National Medical Research Center 'Medical and Rehabilitation Center'" of the Ministry of Health of the Russian Federation

    Moscow, 125367

  • Research Lab LLC

    Moscow, 127521

  • Joint-Stock Company "Medsi Group of Companies"

    Moscow, 143442

  • LLC MSCh "Klinitsist-Klinika Pretor"

    Novosibirsk, 630091

  • Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of Saint-Petersburg"

    Saint Petersburg, 195271

  • City Clinical Oncology Dispensary (Saint Petersburg)

    Saint Petersburg, 198255

  • Siberian State Medical University

    Tomsk, 634063

  • Multidisciplinary Clinical Medical Center "Medical City"

    Tyumen, 625041

  • State Institution of Healthcare of Yaroslavl Region "Regional Oncology Hospital"

    Yaroslavl, 150054

Other trials in Russia

About this study

Official title: A Phase II, Open-label, Randomized, Comparative Dose-finding Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer

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

Read the detailed description

This is an open-label, randomized, comparative phase II clinical trial conducted in 4 treatment arms:

  • Arm 1: RS-113 160 mg (2 capsules) once daily (QD)
  • Arm 2: RS-113 240 mg (3 capsules) QD
  • Arm 3: RS-113 320 mg (4 capsules) QD
  • Arm 4: abiraterone 1000 mg (4 tablets) QD plus prednisolone 10 mg QD

All enrolled patients who have not previously undergone a surgical castration will receive androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) analogues throughout the study

The study will include the following periods:

  1. Screening period: up to 28 days Days [-27 to -0] prior to the first dose of the study treatment
  2. Core study: up to 2 years Days [1 to 728] Eligible patients should be randomized to one of four treatment arms (in a 1:1:1:1 ratio):
  • Arm 1: RS-113 160 mg (2 capsules) QD
  • Arm 2: RS-113 240 mg (3 capsules) QD
  • Arm 3: RS-113 320 mg (4 capsules) QD
  • Arm 4: abiraterone 1000 mg (4 tablets) QD plus prednisolone 10 mg QD During the core study, the treatment will continue until the earliest of the following:
  • Day 728 (+7 days)
  • Disease progression (per RECIST 1.1 and PCWG3 criteria)
  • Unacceptable toxicity
  • Patient withdrawal from the study During the core study tumor response assessments will be performed approximately every 8 weeks for the first 24 weeks, and every 12 weeks thereafter
  1. Extension phase Patients who had stable disease or tumor response within 2 years of treatment may be enrolled in an extension study. During the Extension phase, patients will continue to receive the same treatment regimen as assigned in the Core study During the Extension phase, the treatment will be administered from Day 728 until the earliest of the following:
  • Disease progression
  • Unacceptable toxicity
  • Patient withdrawal from the study
  1. Follow-up period (follow-up/FU)
  • Patients who complete the planned 2-year study treatment and are not enrolled in the Extension phase will have one in-person Follow-up (FU) visit 28±3 days after the last dose of investigational product/comparator. This will be the final study visit for these patients. Subsequent treatment will be provided through the national healthcare system (as part of routine clinical practice) if indicated.
  • Patients who discontinue treatment early due to disease progression will have one in-person FU visit 28±3 days after the last dose of investigational product/comparator (for safety data collection). Thereafter, follow-up will be conducted via telephone contacts every 12 weeks until Day 728 or death (for survival data collection).
  • Patients who discontinue treatment early for reasons other than disease progression will have one in-person FU visit 28±3 days after the last dose of investigational product/comparator (for safety data collection). Subsequently, they will undergo FU visits with tumor response assessments every 8 weeks until Day 169, and then every 12 weeks until Day 728, disease progression, or initiation of new treatment, whichever occurs first

Completing the last visit means the end of participation in the clinical trial for each particular patient

Being tested
RS-113, 160 mg, RS-113, 240 mg, RS-113, 320 mg, Abiraterone, Prednisolone
Keywords
Metastatic Castration-resistant Prostate Cancer, RS-113

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RS-113, 160 mgDrug

    Also called L01069

    Hard gelatin capsules, 80 mg

  • RS-113, 240 mgDrug

    Also called L01069

    Hard gelatin capsules, 80 mg

  • RS-113, 320 mgDrug

    Also called L01069

    Hard gelatin capsules, 80 mg

  • AbirateroneDrug

    Tablets, 250 mg

  • PrednisoloneDrug

    Tablets, 5 mg

  • Androgen deprivation therapy (ADT)Drug

    • Goserelin: subcutaneous implant, 3.6 mg or 10.8 mg, or
    • Leuprorelin: lyophilisate for solution for subcutaneous injection, 7.5 mg or 22.5 mg, or
    • Triptorelin: lyophilisate for solution for intramuscular injection, 3.75 mg, or
    • Buserelin: lyophilisate for solution for intramuscular injection, 3.75 mg
Study groups in NCT07553988
Study groupRoleWhat they receive
RS-113, 160 mg + androgen deprivation therapy (ADT)ExperimentalRS-113 is taken once daily (QD) orally, 2 capsules at a time (160 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Receives: Drug: RS-113, 160 mg; Drug: Androgen deprivation therapy (ADT)
RS-113, 240 mg + androgen deprivation therapy (ADT)ExperimentalRS-113 is taken orally QD, 3 capsules at a time (240 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Receives: Drug: RS-113, 240 mg; Drug: Androgen deprivation therapy (ADT)
RS-113, 320 mg + androgen-deprivation therapy (ADT)ExperimentalRS-113 is taken orally QD, 4 capsules at a time (320 mg), 1 hour after a meal in the morning Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Receives: Drug: RS-113, 320 mg; Drug: Androgen deprivation therapy (ADT)
Abiraterone + prednisolone + androgen deprivation therapy (ADT)Active comparatorAbiraterone is taken at a dose of 1000 mg (4 tablets of 250 mg) QD, 1 hour before a meal or 2 hours after a meal in combination with prednisolone at a dose of 10 mg (2 tablets of 5 mg) QD Androgen deprivation therapy (ADT) will be administered using analogues of luteinizing hormone-releasing hormone (aLHRH): * goserelin (at a dose of 3.6mg every 28 days or 10.8 mg every 84 days, subcutaneously, into the anterior abdominal wall), or * leuprorelin (7.5 mg every 28 days or 22.5 mg every 3 months, subcutaneously, into the anterior abdominal wall), or * triptorelin (3.75 mg every 28 days intramuscularly), or * buserelin (3.75 mg every 28 days, intramuscularly)
Receives: Drug: Abiraterone; Drug: Prednisolone; Drug: Androgen deprivation therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms

    Progression-free survival (PFS) expressed as the median PFS for a period of up to 1 year of treatment inclusive in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria)

    PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause

    According to PCWG3, progression is defined as:

    • two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan
    • two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan

    Measured: Up to day 337 (visit 16)

Secondary outcomes (19)

  1. Progression-free survival (PFS) rate (%) at 1 year in RS-113 treatment arms

    Progression-free survival (PFS) expressed as the rate (%) at 1 year PFS in RS-113 treatment arms (per RECIST 1.1 and PCWG3 criteria)

    PFS is defined as the time from randomization to disease progression per RECIST 1.1 (an ≥ 20% increase in the sum of diameters of target lesions taking as reference the smallest sum recorded during the study (with an absolute increase of sum at least 5 mm), or the appearance of ≥ 1 new lesions), or death due to any cause

    According to PCWG3, progression is defined as:

    • two or more new lesions detected on the first post-baseline scan with at least 2 additional lesions on a subsequent scan
    • two or more new lesions detected on a subsequent scan (if one or no new lesions were seen at the first post-baseline scan) and confirmed by a follow-up scan

    Measured: Up to day 337 (visit 16)

  2. Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms

    Prostate-specific antigen (PSA) response rate (%) in RS-113 treatment arms

    Measured: at Week 9, 21, 33, 45, 57, 69, 81, 93, 101 and FU visit

  3. Number (%) of patients achieved ≥50% prostate-specific antigen (PSA) decline in RS-113 treatment arms

    Number (%) of patients achieved ≥50% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arms

    Defined as a ≥50% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later

    Measured: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit

  4. Number (%) of patients achieved ≥90% prostate-specific antigen (PSA) decline in RS-113 treatment arm

    Number (%) of patients achieved ≥90% PSA decline at 6, 12, 18 and 24 months in RS-113 treatment arm

    Defined as a ≥90% reduction in PSA level from baseline at any time post-baseline. The response must be confirmed by the next PSA assessment performed at least 2 weeks later

    Measured: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit

  5. Objective response rate (ORR)(%) at 1 year in RS-113 treatment arms

    The objective response rate (ORR)(%) is defined as the percentage of patients in RS-113 treatment arms who achieve a complete or partial response per RECIST 1.1:

    • Complete response (CR): disappearance of all target lesions confirmed by CT for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be < 10 mm
    • Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions sustained for at least 4 weeks taking as reference the baseline sum at screening

    Measured: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit

  6. Disease control rate (DCR)(%) at 1 year in RS-113 treatment arms

    The disease control rate is defined as the percentage of patients in RS-113 treatment arms who achieve a complete response, partial response, or stable disease during treatment per RECIST 1.1:

    • Complete Response (CR) - disappearance of all target lesions, confirmed by CT scans for at least 4 weeks; the short axis of any lymph node previously considered pathological (target or non-target) must be <10 mm
    • Partial Response (PR) - at least a 30% decrease in the sum of diameters of target lesions, maintained for at least 4 weeks taking as reference the baseline (screening) measurements
    • Stable Disease (SD) - neither sufficient shrinkage in the sum of diameters to qualify as partial response nor sufficient increase to qualify as progressive disease taking as reference the smallest sum recorded during the study

    Measured: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit

  7. Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms

    Time to Tumor Response (TTR) at 1 year in RS-113 treatment arms

    Measured: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit

  8. Duration of Response (DOR) at 1 year in RS-113 treatment arms

    Duration of Response (DOR) at 1 year in RS-113 treatment arms

    Measured: once at screening, on days 57 (visit 5), 113 (visit 8), 169 (visit 10), 253 (visit 13), 337 (visit 16) and FU visit

  9. Time to prostate-specific antigen (PSA) progression in RS-113 treatment arms

    Time to PSA progression is the time from randomization to the earliest date of confirmed PSA progression (per PCWG3 criteria). The date of PSA progression is defined as the date of a documented ≥25% increase in PSA and an absolute increase of ≥2 ng/mL above the nadir (or above baseline for patients with no PSA decline by Week 12), confirmed by two consecutive values obtained at least 3 weeks apart

    Measured: once at screening, on days 29 (visit 3), 57 (visit 5), 85-701 (visits 7-29) and FU visit

  10. Radiographic Progression-Free Survival (rPFS) at 1 year in RS-113 treatment arms

    Radiographic Progression-Free Survival (rPFS) in RS-113 treatment arms, expressed as median rPFS for a period of up to 1 year of treatment inclusive (defined as the time from randomization to the first objective evidence of radiographic disease progression per RECIST 1.1 criteria or death due to any cause)

    Measured: Up to day 337 (visit 16)

  11. Overall survival (OS) rate (%) at 1 year in RS-113 treatment arms

    Overall survival (OS) expressed as the rate (%) at 1 year OS in RS-113 treatment arms

    Measured: Up to day 337 (visit 16)

  12. Number of patients (%) with adverse drug reactions (ADRs) of any severity

    Number of patients (%) with adverse drug reactions (ADRs) of any severity

    Measured: Up to day 701 (visit 29)

  13. Number of patients (%) with adverse events (AEs) of any severity

    Number of patients (%) with adverse events (AEs) of any severity

    Measured: Up to day 701 (visit 29)

  14. Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0

    Number of patients (%) with AEs grade ≥ 3 per CTCAE v. 5.0

    Measured: Up to day 701 (visit 29)

  15. Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0

    Number of patients (%) with ADRs grade ≥ 3 per CTCAE v. 5.0

    Measured: Up to day 701 (visit 29)

  16. Number of patients (%) with serious adverse events (SAEs)

    Number of patients (%) with serious adverse events (SAEs)

    SAEs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

    Measured: Up to day 701 (visit 29)

  17. Number of patients (%) with serious adverse drug reactions (SADRs)

    Number of patients (%) with serious adverse drug reactions (SADRs)

    SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

    Measured: Up to day 701 (visit 29)

  18. Number of patients (%) who required discontinuation of treatment due to development of ADRs

    Number of patients (%) who required discontinuation of treatment due to development of ADRs

    ADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

    Measured: Up to day 701 (visit 29)

  19. Number of patients (%) who required discontinuation of treatment due to development of SADRs

    Number of patients (%) who required discontinuation of treatment due to development of SADRs

    SADRs will be graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

    Measured: Up to day 701 (visit 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2026
  2. Study start24 Oct 2024
  3. Primary completion14 May 2026 (estimated)
  4. Study completion9 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07553988
Sponsor's protocol ID
CL01069052
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RS-113, 160 mg, RS-113, 240 mg and RS-113, 320 mg in people with Metastatic Castration-resistant Prostate Cancer, run by R-Pharm International, LLC at 16 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Progression-free survival (PFS) at 1 year in RS-113 treatment arms (time frame: Up to day 337 (visit 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07553988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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