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I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).
Phase 2 trial testing I-131-1095 in Metastatic Prostate Cancer in 120 participants. Completed in 24 September 2024.
| Lead sponsor | Progenics Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 30 May 2019 |
| Primary completion | 21 September 2023 |
| Estimated completion | 24 September 2024 |
| Sites | 27 locations across Canada, United States |
Progenics Pharmaceuticals, Inc. — full company profile →
18 and older, male only, with Metastatic Prostate Cancer or Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of participants with a PSA response according to PCWG3 criteria. PCWG3 defines PSA response as the first occurrence of a 50 percent or more decline in PSA from baseline, confirmed by a second measurement at least 3 weeks later.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 10 | |
| I-131-1095 in Combination With Enzalutamide | 44 |
The proportion of participants who have a partial response (PR) or complete response (CR) based on RECIST 1.1 for soft tissue or PCWG3 for bone (PCWG3-modified RECIST 1.1).
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 4 | |
| I-131-1095 in Combination With Enzalutamide | 7 |
Time from randomization to the first occurrence of radiographic progression based on RECIST 1.1 for soft tissue (≥20% increase in the sum of the longest diameter of the target lesions \[relative to the smallest value recorded since the treatment started\] or the appearance of ≥1 new lesion) or PCWG3-modified RECIST 1.1 for bone, respectively, or unequivocal clinical progression, or death on study from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 11.5 | 2.79 – 18.43 |
| I-131-1095 in Combination With Enzalutamide | 14.0 | 8.64 – 18.20 |
Overall Survival is defined as time from randomization to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 22.0 | 14.59 – NA |
| I-131-1095 in Combination With Enzalutamide | 18.8 | 15.34 – 29.47 |
Time from randomization to the date of the first PSA increase from baseline ≥ 25 percent and ≥ 2 ng/ml above nadir confirmed by a second PSA assessment defining progression ≥ 3 weeks later per PCWG3.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 10 | 3.45 – NA |
| I-131-1095 in Combination With Enzalutamide | NA | 6.97 – NA |
Time from the first date of complete response (CR) or partial response (PR) to the first occurrence of radiographic progression based on PCWG3-modified RECIST 1.1, or unequivocal clinical progression. Complete response was defined as disappearance of all target lesions. Partial response was defined as ≥30% decrease from baseline in the sum of the longest diameter of target lesions.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 15.1 | 3.29 – NA |
| I-131-1095 in Combination With Enzalutamide | 15.0 | 3.29 – NA |
Time from randomization to initiation of any new treatment for prostate cancer.
| Group | Value | 95% CI |
|---|---|---|
| Enzalutamide | 10.9 | 5.16 – 13.60 |
| I-131-1095 in Combination With Enzalutamide | 18.3 | 13.14 – NA |
Time frame: Randomized treatment phase (up to 53 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Enzalutamide | I-131-1095 in Combination … |
|---|---|---|---|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Pancytopenia | Blood and lymphatic system disorders | — | — |
| Platelet count decreased/Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Aplastic anaemia | Blood and lymphatic system disorders | — | — |
| Bone marrow failure | Blood and lymphatic system disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| White blood cell count decreased/Leukopenia | Blood and lymphatic system disorders | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — |
| Atrial tachycardia | Cardiac disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Large intestinal stenosis | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Fatigue/Asthenia | General disorders | — | — |
| Abdominal infection | Gastrointestinal disorders | — | — |
| Reaction | System | Enzalutamide | I-131-1095 in Combination … |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Platelet count decreased | Blood and lymphatic system disorders | — | — |
| Weight decreased | Immune system disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Lymphocyte count decreased | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Blood thyroid stimulating hormone increased | Investigations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — | — |
| White blood cell count decreased | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Chills | General disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hot flush | Vascular disorders | — | — |
Most-reported serious reactions: Myelodysplastic syndrome, Anemia, Pancytopenia, Platelet count decreased/Thrombocytopenia, Sepsis, Fall, Dehydration, Muscular weakness.
Data from ClinicalTrials.gov NCT03939689 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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