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Radiation Therapy

Radiation + Standard Care for Metastatic Prostate Cancer

Phase 2
Waitlist Available
Led By Zachery Reichert, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG ≤ 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death)
Subjects must have oligometastatic prostate cancer, defined as between 1 and ≤5 treatment sites that can be treated within a radiotherapy treatment field.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and at 24 months
Awards & highlights

Study Summary

This trial will see if adding radiation to the current standard of care for prostate cancer that has spread to a few other parts of the body improves how well the treatment works.

Who is the study for?
Men over 18 with advanced prostate cancer that has spread to a limited number of places (1-5 sites) and is resistant to hormone therapy can join. They must be healthy enough for radiation and systemic therapy, not have had other cancers in the last 3 years (some exceptions apply), and agree to use contraception after treatment.Check my eligibility
What is being tested?
The trial tests if adding radiotherapy to standard treatments like hormone or chemotherapy helps slow down cancer growth better than standard treatments alone in men with a few metastatic spots of castration-resistant prostate cancer.See study design
What are the potential side effects?
Radiation may cause skin irritation, fatigue, digestive issues, urinary problems, and sexual dysfunction. Hormone therapy might lead to hot flashes, weakened bones, reduced libido, mood changes. Chemotherapy's side effects include nausea, hair loss, increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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My prostate cancer has spread to 5 or fewer areas that can be targeted with radiation.
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I am 18 years old or older.
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My prostate cancer was confirmed by a biopsy.
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My prostate cancer is worsening despite low testosterone levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and at 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and at 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median duration of response
Secondary outcome measures
Median objective progression free survival (PFS) time
Median prostate specific antigen (PSA) PFS
Median radiographic PFS
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + Ablative RadiationExperimental Treatment2 Interventions
Standard of care systemic therapy plus radiation. Radiation will start within 8 weeks of randomization and complete by day 84. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.
Group II: Standard of CareActive Control1 Intervention
Standard of care therapy will be up to the treating medical oncologist and is not the study intervention. Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel, cabazitaxel) are allowed. Patients should begin systemic treatment within 3 weeks of randomization. Standard of care systemic therapy may continue in the absence of toxicities or other specific criteria per protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ablative Radiation Therapy
2018
Completed Phase 2
~20
Enzalutamide
FDA approved

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,258 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,973 Patients Enrolled for Prostate Cancer
Zachery Reichert, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
2 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Prostate Cancer
29 Patients Enrolled for Prostate Cancer

Media Library

Ablative Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03556904 — Phase 2
Prostate Cancer Research Study Groups: Standard of Care, Standard of Care + Ablative Radiation
Prostate Cancer Clinical Trial 2023: Ablative Radiation Therapy Highlights & Side Effects. Trial Name: NCT03556904 — Phase 2
Ablative Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03556904 — Phase 2
~2 spots leftby Jun 2025
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