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Antiandrogen

I-131-1095 + Enzalutamide for Prostate Cancer (ARROW Trial)

Phase 2

Waitlist Available

Research Sponsored by Progenics Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 53 (concomitant medications); from week 54 up to 5 years (anti-cancer therapies only)

Awards & highlights

ARROW Trial Summary

This trial is designed to see if I-131-1095 radiotherapy in combination with enzalutamide is safe and more effective than just enzalutamide alone in treating prostate cancer that has progressed despite treatment with abiraterone and that has spread to other parts of the body.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, but haven't had chemotherapy. They must have worsening disease despite previous treatment with abiraterone, be ineligible or refuse taxane-based chemo, and agree to use birth control. Excluded are those who've taken enzalutamide before or have certain health issues like poor organ function or a history of seizures.Check my eligibility

What is being tested?

This phase 2 trial tests if I-131-1095 radiotherapy plus enzalutamide is better than enzalutamide alone for men whose prostate cancer worsens after abiraterone treatment. Participants' tumors must show PSMA presence on scans. The study randomly assigns patients in a 2:1 ratio to either the combination therapy or just enzalutamide.See study design

What are the potential side effects?

Possible side effects include typical reactions from radiation such as nausea, fatigue, and blood count changes; and from enzalutamide like hot flashes, fatigue again, muscle weakness, and potentially seizures in predisposed individuals.

ARROW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a steady dose of bisphosphonate therapy for at least 4 weeks.

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I do not have severe nerve damage or major heart problems.

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My bone scan shows two or more new lesions indicating my disease is progressing.

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I am scheduled to start treatment with enzalutamide.

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My cancer has worsened despite taking abiraterone.

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I have a history of cancer that might have returned or spread.

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I can take care of myself and am up and about more than half of the day.

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My prostate cancer was confirmed without specific aggressive features.

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My prostate cancer is not responding to hormone therapy, and my testosterone levels are low.

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I have difficulty performing daily activities.

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I am a man aged 18 or older.

ARROW Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 53 (concomitant medications); from week 54 up to 5 years (anti-cancer therapies only)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 53 (concomitant medications); from week 54 up to 5 years (anti-cancer therapies only)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 53 (concomitant medications); from week 54 up to 5 years (anti-cancer therapies only) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PSA Response Rate

Secondary outcome measures

Adverse Events Resulting In Discontinuation Of Study Drug (Safety Outcome Measure)

Changes From Baseline In Overall Electrocardiogram (ECG) Assessment At Follow-up (Safety Outcome Measure)

Changes In Blood Pressure (Safety Outcome Measure)

+13 more

ARROW Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: I-131-1095 in combination with enzalutamideExperimental Treatment2 Interventions

Group II: EnzalutamideActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Progenics Pharmaceuticals, Inc.Lead Sponsor

33 Previous Clinical Trials

4,830 Total Patients Enrolled

17 Trials studying Prostate Cancer

2,214 Patients Enrolled for Prostate Cancer

Istvan Molnar, MDStudy DirectorProgenics Pharmaceuticals, Inc.

3 Previous Clinical Trials

5 Total Patients Enrolled

Jean-Claude Provost, MDStudy DirectorProgenics Pharmaceuticals, Inc.

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT03939689 — Phase 2

Prostate Cancer Research Study Groups: I-131-1095 in combination with enzalutamide, Enzalutamide

Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT03939689 — Phase 2

Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03939689 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards does I-131-1095 pose to humans?

"Our company's evaluation of I-131-1095 safety yields a rating of 2, as this is Phase 2 trial and there are data points to back up its safe usage but none that prove efficacy."

Answered by AI

In what locations is this research currently being conducted?

"This investigation is being conducted in 25 distinct medical centres, with a few of the sites located in Montreal, Philadelphia and Sherbrooke. To cut down on travel demands, it's imperative to select the closest available site when considering participation."

Answered by AI

Are there any potential participants able to join this investigation?

"This research project is no longer admitting new participants. It was initially listed on May 30th 2019, and the last update was August 3rd 2022. For those still looking for clinical trials, there are currently 1324 studies recruiting patients with prostate cancer, as well as 98 related to I-131-1095 that require volunteers."

Answered by AI

How many participants are involved in this research endeavor?

"As of now, this clinical trial is not actively enrolling patients. Initially posted on May 30th 2019 and most recently updated on August 3rd 2022, there are many other trials that may be a better fit for prospective participants; 1324 studies related to prostate cancer and 98 concerning I-131-1095 are presently recruiting individuals."

Answered by AI

Are there any previous studies involving I-131-1095 that can be referred to?

"At this moment, 98 clinical trials that focus on I-131-1095 have been set up with 30 of them in their terminal phase. Though the majority are situated within Germantown, Tennessee, there are 5,738 separate locations hosting these tests for I-131-1095."

Answered by AI

What objectives does this clinical experiment seek to accomplish?

"According to the study sponsor, Progenics Pharmaceuticals, Inc., efficacy is measured over a 12 month period in terms of PSA Response Rate. Additionally, secondary outcomes are monitored such as Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events As Assessed by CTCAE v5.0, Clinically Significant Changes In Blood Pressure and Shift From Baseline In Selected Clinical Chemistry Laboratory Values At Follow-up."

Answered by AI