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Hormone Therapy

MDRT + ADT for Prostate Cancer

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years after treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years after treatment

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

Treatment Details

Study Objectives

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

Primary outcome measures

Failure-free survival (FFS)

Secondary outcome measures

Change in EPIC-26 Bowel Domain Score

Change in EPIC-26 Hormone Domain Score

Change in EPIC-26 Sexual Domain Score

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SST + RT + 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: SST + RTActive 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,178 Total Patients Enrolled

28 Trials studying Prostate Cancer

6,757 Patients Enrolled for Prostate Cancer

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,669 Total Patients Enrolled

31 Trials studying Prostate Cancer

2,913 Patients Enrolled for Prostate Cancer

Angela Y Jia, MD, PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Frequently Asked Questions

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

Are there any unfilled vacancies for participants in this experiment?

"According to the clinicaltrials.gov portal, this trial is not presently seeking volunteers; it was posted on April 1st 2024 and edited lastly on November 21st 2023. Despite that, there are still 3,902 other medical trials actively looking for participants."

Answered by AI

Can you clarify the safety implications of administering SST + RT + MDRT to patients?

"With only limited data available on the safety of SST + RT + MDRT, our team at Power assessed this intervention with a score 2. As it is currently in Phase 2, sufficient clinical evidence regarding its efficacy has yet to be collected."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

2024. "MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150417.