I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).

Completed · Phase 2

Conditions studied: Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Prostatic Neoplasm, Cancer of the Prostate, Progressive mCRPC

In brief

This clinical trial was done to show whether a radioactive drug (I-131-1095) that binds to prostate-specific membrane antigen (PSMA) is useful in treating metastatic prostate cancer that is positive for PSMA. The trial enrolled men whose PSMA-positive metastatic prostate cancer had progressed while they were taking abiraterone. During the trial, all of the men took enzalutamide (standard-of-care therapy) once a day. However, some of the men also had up to 4 doses (8 weeks apart) of I-131-1095 (in addition to taking enzalutamide once a day). At specified times during the trial, all of the men had blood tests (to measure levels of prostate-specific antigen \[PSA\]) and imaging studies (to assess tumor status). The two groups of men were then compared in several ways. The main comparison was the percentage of men in each group with at least a 50% decrease in PSA levels. Other comparisons involved the response of the tumors (as seen on imaging) and overall survival. To assess safety, the number of adverse events in both groups were also compared.

Key facts

Study ID

NCT03939689

Run by

Progenics Pharmaceuticals, Inc.

People needed

120

Starts

2019-05-30

Expected to finish

2024-09-24

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male ≥ 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
• Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening
• Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening
• Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator:
• PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart
• Soft tissue disease progression defined by RECIST 1.1
• Bone disease progression defined by two or more new lesions on bone scan
• Planned to receive treatment with enzalutamide
• Subjects who are ineligible or choose not to receive taxane-based chemotherapy based on personal preference or physician opinion. Examples of conditions that could make a patient ineligible or refuse to receive taxane-based chemotherapy, but would allow them to still be eligible to receive I-131-1095 include the following:
• Poor performance status
• Prior intolerance to cytotoxic agents
• History of another malignancy suspected for recurrence or metastases
• Other serious medical conditions such as symptomatic peripheral neuropathy CTCAE Grade 2 or higher; or clinically significant cardiovascular disease per the Investigator or treating physician
• Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization
• ECOG performance status 0-2
• If sexually active, agree to use a medically acceptable method of birth control or sexual abstinence from the time of dosing through 28 days after the last dose of I-131-1095. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
• Estimated life expectancy of at least 6 months as determined by the Investigator.
• Able and willing to provide signed informed consent and comply with protocol requirements

You may not qualify if…

• Received any anti-tumor therapy within 4 weeks of Randomization, with the exception of abiraterone, GnRH therapy and non-radioactive bone-targeted agents
• Received prior chemotherapy for castration-resistant prostate cancer
• Superscan as evidenced on baseline bone scan
• Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 within 6 months prior to Randomization
• Prior hemi-body irradiation
• Prior PSMA-targeted radioligand therapy
• Major surgery within 4 weeks of Randomization
• Impaired organ function as evidenced by the following laboratory values at Screening:
• Absolute neutrophil count < 1500 μL
• Platelet count < 100,000/μL
• Hemoglobin < 9.5 g/dL
• Albumin < 3.0 g/dL (30 g/L)
• Total bilirubin > 2 x ULN unless in instances of known or suspected Gilbert's disease
• AST or ALT > 2.5 x ULN
• Calculated creatinine clearance (CrCL) < 30 mL/min (Cockroft-Gault equation), or currently on renal dialysis.
• QT interval corrected for heart rate (QTc) > 470 msec
• Previous use of enzalutamide for more than 7 days prior to consent
• Planned initiation of alternative therapy for prostate cancer, investigational therapy, or participation in clinical trials during the study
• History or risk of seizure (i.e., clinically significant neurological disorder) or any other condition that contraindicates treatment with enzalutamide
• Gastrointestinal disorder affecting absorption of oral medications
• Known or suspected brain metastasis or active leptomeningeal disease
• Active malignancy other than prostate cancer, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or non-muscle invasive bladder/urothelial cancer
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study.

Where it is running

• City of Hope — Duarte, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Hoag Family Cancer Institute — Newport Beach, California, United States
• VA Palo Alto Healthcare System — Palo Alto, California, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• The University of Chicago — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Tulane Medical School — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• LifeSpan Cancer Institute — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• University of Washington - Seattle Cancer Care Alliance — Seattle, Washington, United States
• The Ottawa Hospital — Ottawa, Ontario, Canada
• London Health Sciences Centre — Toronto, Ontario, Canada
• University Health Network - Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Centre Hospitalier Del' Universite de Montreal — Montreal, Quebec, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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