Actively Recruiting
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
90
Participants Needed
32
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.
CONDITIONS
Official Title
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase 1 patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score 70% or higher); Phase 2 patients must have ECOG 0, 1, or 2 (Karnofsky score 60% or higher)
- Patients must be on continuous antiandrogen therapy if not surgically castrated, maintaining testosterone levels below 50 ng/dL
- Must have progressive castration-resistant prostate cancer with two or more bone metastases shown by bone scan; lymph node metastases under 3 cm allowed; no visible visceral organ metastases
- Histologically confirmed prostate cancer
- Baseline PSA level 1 ng/mL or higher with evidence of increasing PSA on two consecutive tests
- Disease progression after at least one prior therapy such as abiraterone, enzalutamide, apalutamide, darolutamide, or taxane chemotherapy
- Age 18 years or older
- Life expectancy of at least 6 months
- Albumin level above 2.5 mg/dL
- Hemoglobin level above 9 g/dL
- Leukocyte count at least 3,000/mcL
- Absolute neutrophil count at least 1,500/mcL
- Platelet count at least 100,000/mcL
- Total bilirubin at or below 1.5 times the institutional upper limit of normal (ULN), except up to 3 mg/dL for Gilbert's disease
- AST/ALT levels at or below 3 times institutional ULN
- Creatinine at or below 1.5 times institutional ULN or glomerular filtration rate at least 40 mL/min/1.73 m2
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible
- Patients with controlled hepatitis B or cured hepatitis C infection are eligible under specified conditions
- Patients with prior or concurrent cancers that do not interfere with study assessments are eligible
- Patients with cardiac function classified as New York Heart Association class 2B or better
- Use of physiologic corticosteroids and bone health agents (denosumab preferred or bisphosphonates) is allowed and mandatory
- Men must agree to use adequate contraception during and for 6 months after treatment
- Ability to understand and sign informed consent; those with impaired decision-making may participate with a legally authorized representative
- Ability to swallow oral medication
- Patients with treated, asymptomatic brain metastases without progression for at least 4 weeks are eligible
You will not qualify if you...
- Active autoimmune disease or on chronic immunosuppression for autoimmune conditions
- Chemotherapy or radiotherapy within 4 weeks before study entry
- Unresolved side effects from prior cancer treatments above grade 1 except alopecia
- Receiving other investigational drugs
- Prior hemibody external radiation
- Imminent or established spinal cord compression, untreated pathological fractures in weight-bearing bones, or bone lesions with soft tissue unless treated
- Known allergy to radium-223 dichloride, M3814, or avelumab or similar compounds
- Unable to stop medications that strongly affect CYP3A4/5 or CYP2C19 enzymes before treatment
- Concurrent use of radium-223 with abiraterone plus prednisone or prednisolone
- Uncontrolled illnesses
- Psychiatric or social conditions limiting compliance
- Active infections needing systemic treatment
- Use of immunosuppressive medication within 7 days before registration except specified low-dose or topical steroids
- Inability to stop H2 blockers or proton-pump inhibitors at least 5 days before treatment
- Use of sorivudine or related drugs
- History or presence of osteonecrosis of the jaw
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
4
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
5
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Active, Not Recruiting
6
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
12
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Active, Not Recruiting
13
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
14
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Active, Not Recruiting
15
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Active, Not Recruiting
16
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
17
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Active, Not Recruiting
18
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Active, Not Recruiting
19
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
20
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Suspended
21
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
22
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
23
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Active, Not Recruiting
24
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
25
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
26
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Active, Not Recruiting
27
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Active, Not Recruiting
28
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
29
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
30
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
31
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Suspended
32
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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