Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apalutamide, Carotuximab.
- Who it may be relevant to
- Registry conditions: Castration-resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Overview
This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
Interventions
- Drug Apalutamide
Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle - Drug Carotuximab
Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose.
Primary outcome measures
- Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab [Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
Secondary outcome measures (6)
- Incidence of Adverse events (grade 3 or higher) related to carotuximab and apalutamide [Time frame: From start of study treatment through 4 weeks on treatment]
- Overall radiographic response rate (ORR) of the combination of apalutamide + carotuximab [Time frame: From the start of combination study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
- Proportion of patients resistant to apalutamide benefit from the addition of carotuximab [Time frame: From the start of combination therapy study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
- Overall radiographic response rate (ORR) in the overall population [Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
- To determine the radiographic progression free survival (rPFS) in the overall population [Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
- To determine the biochemical PFS (by PCWG3) in the overall population [Time frame: From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.]
Eligibility criteria
Inclusion criteria
- History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
- Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
- Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
- All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)
Exclusion criteria
- Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise
- Prior use of apalutamide
- Other prior malignancy requiring active anticancer therapy
- Prior exposure to carotuximab or any CD105 targeted antibody
- Active bleeding or pathologic medical conditions that carries a high bleeding risk
- A known diagnosis of Osler-Weber-Rendu syndrome
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- City of Hope — Duarte
- Cedars-Sinai Medical Center — Los Angeles
- Huntsman Cancer Institute and Hospital — Salt Lake City
Identifiers
NCT: NCT05534646 · IIT2021-06-Posadas-APA105