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Radioactive therapy shows promise for tough prostate cancer

NCT ID NCT03939689

Disease control Sponsor: Progenics Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether adding a radioactive drug (I-131-1095) to standard enzalutamide therapy helps men with a specific type of advanced prostate cancer that had worsened on another treatment. The study enrolled 120 men with PSMA-positive metastatic castration-resistant prostate cancer. Some received the radioactive drug plus enzalutamide, while others got enzalutamide alone. Researchers compared PSA levels, tumor response, and side effects between the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
I-131-1095 (radioactive drug) and enzalutamide
What this could lead to
If it works, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is a phase 2 trial with only 120 participants, so results may not apply to everyone. The radioactive drug can cause side effects like low blood cell counts, and it's not yet proven to improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

May 2019

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male ≥ 18 years of age 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis 3. Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening 4. Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening 5. Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator: 1. PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart 2. Soft tissue disease progression defined by RECIST 1.1 3. Bone disease progression defined by two or more new lesions on bone scan 6. Planned to receive treatment with enzalutamide 7. 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: 1. Poor performance status 2. Prior intolerance to cytotoxic agents 3. History of another malignancy suspected for recurrence or metastases 4. 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 8. Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization 9. ECOG performance status 0-2 10. 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. 11. Estimated life expectancy of at least 6 months as determined by the Investigator. 12. Able and willing to provide signed informed consent and comply with protocol requirements Exclusion Criteria: 1. Received any anti-tumor therapy within 4 weeks of Randomization, with the exception of abiraterone, GnRH therapy and non-radioactive bone-targeted agents 2. Received prior chemotherapy for castration-resistant prostate cancer 3. Superscan as evidenced on baseline bone scan 4. Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 within 6 months prior to Randomization 5. Prior hemi-body irradiation 6. Prior PSMA-targeted radioligand therapy 7. Major surgery within 4 weeks of Randomization 8. Impaired organ function as evidenced by the following laboratory values at Screening: 1. Absolute neutrophil count \< 1500 μL 2. Platelet count \< 100,000/μL 3. Hemoglobin \< 9.5 g/dL 4. Albumin \< 3.0 g/dL (30 g/L) 5. Total bilirubin \> 2 x ULN unless in instances of known or suspected Gilbert's disease 6. AST or ALT \> 2.5 x ULN 7. Calculated creatinine clearance (CrCL) \< 30 mL/min (Cockroft-Gault equation), or currently on renal dialysis. 9. QT interval corrected for heart rate (QTc) \> 470 msec 10. Previous use of enzalutamide for more than 7 days prior to consent 11. Planned initiation of alternative therapy for prostate cancer, investigational therapy, or participation in clinical trials during the study 12. History or risk of seizure (i.e., clinically significant neurological disorder) or any other condition that contraindicates treatment with enzalutamide 13. Gastrointestinal disorder affecting absorption of oral medications 14. Known or suspected brain metastasis or active leptomeningeal disease 15. 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 16. 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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer of the prostate Castration-resistant prostate cancer Metastatic prostate cancer Progressive MCRPC Prostatic neoplasm

Contacts and locations

Locations

  • Centre Hospitalier Del' Universite de Montreal

    Montreal, Quebec, Canada

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, Canada

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, Canada

  • City of Hope

    Duarte, California, 91010, United States

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663, United States

  • Jewish General Hospital

    Montreal, Quebec, Canada

  • LifeSpan Cancer Institute

    Providence, Rhode Island, 09206, United States

  • London Health Sciences Centre

    Toronto, Ontario, Canada

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • Tulane Medical School

    New Orleans, Louisiana, 70112, United States

  • UCLA

    Los Angeles, California, 90095-7370, United States

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073, United States

  • VA Palo Alto Healthcare System

    Palo Alto, California, 94303, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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