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Hormone Therapy

MDRT + ADT for Prostate Cancer

Phase 2

Recruiting

Led By Angela Y Jia, MD, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Participant must be ≥ 18 years of age

Participant must have an ECOG performance status ≤ 1

Must not have

Participants with the presence of any of the following: Castration resistant prostate cancer (CRPC)

Prior definitive treatment to the primary prostate cancer or pelvis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years from treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if giving radiation therapy to areas of metastatic prostate cancer when diagnosed can better control the disease than the usual treatment.

Who is the study for?

Men over 18 with newly diagnosed metastatic prostate cancer, who haven't had prior treatment for it and are fit enough for therapy (ECOG ≤1). They should have evidence of limited spread on scans and be able to start hormone therapy. Excluded are those with resistant cancer, other active cancers within 2 years, or serious health issues that could interfere with the study.

What is being tested?

The trial is testing if adding radiation (MDRT) to areas where prostate cancer has spread improves disease control compared to usual treatments alone. Usual care includes lifelong hormone therapy and possibly prostate RT or surgery. Participants will be randomly chosen to receive either standard care or standard plus MDRT.

What are the potential side effects?

Possible side effects include typical reactions from radiotherapy like skin irritation, fatigue, bowel and urinary issues; hormonal treatments may cause hot flashes, sexual dysfunction, bone thinning; surgery risks include bleeding and infection.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active and can carry on all pre-disease activities without restriction.

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My condition is newly diagnosed and I haven't received any treatment yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is resistant to hormonal therapy.

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I have had treatment aimed at curing my prostate cancer.

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I do not have any severe illnesses that are not under control.

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I have not had any cancer except for non-melanoma skin cancer in the last 2 years.

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My cancer has spread to my organs or brain.

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I cannot lie flat for scans or certain treatments.

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My Crohn's disease or ulcerative colitis is active despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years from treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Failure-free survival (FFS)

Secondary study objectives

Change in EPIC-26 Bowel Domain Score

Change in EPIC-26 Hormone Domain Score

Change in EPIC-26 Sexual Domain Score

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SOC + MDRTExperimental Treatment4 Interventions

* Participants will receive the standard of care. Standard systemic therapy (SST) and definitive local therapy (radiotherapy \[RT\] or radical prostatectomy \[RP\]) are the standard of care for de novo oligometastatic prostate cancer. This arm will be used to compare to the experimental arm. * SST will begin 6 weeks of randomization and occur for 12 months. The definitive local therapy will be RT, with a small portion undergoing RP. Local therapy should be completed by the end of Week 20. * MDRT should be completed by the end of Week 24. Depending on the participant, there are different approaches to MDRT dosing and fraction size.

Group II: Standard of Care (SOC)Active Control3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen deprivation therapy (ADT)

2013

Completed Phase 4

~1310

0 / 10Eligibility criteria met