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Hormone Therapy

Hormone Therapy + Radiation for Prostate Cancer

Phase 2

Recruiting

Led By Carlos E. Vargas, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using fewer hormone therapy treatments along with radiation therapy is as effective as using more hormone therapy treatments in treating high-risk prostate cancer. Hormone therapy lowers the amount of male hormone in

Who is the study for?

This trial is for individuals with prostate cancer, specifically adenocarcinoma. Participants should be suitable for hormone therapy and radiation, and willing to undergo various imaging tests like CT, MRI, PET scans, as well as provide biospecimens. The study aims to tailor the amount of hormone treatment based on individual risk factors.

What is being tested?

The trial is testing a de-escalated (reduced) approach to hormone therapy combined with radiation in treating prostate cancer. It involves using drugs that lower testosterone levels (like LHRH analogs and Zytiga) alongside high-energy treatments aimed at killing cancer cells or shrinking tumors.

What are the potential side effects?

Possible side effects include those from hormone therapy such as fatigue, hot flashes, sexual dysfunction, bone thinning; and from radiation like skin irritation near the treated area, frequent urination or discomfort during urination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hormonal domain scores

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group III (ADT, radiation therapy, abiraterone acetate)Experimental Treatment8 Interventions

Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

Group II: Group II (ADT, radiation therapy)Experimental Treatment7 Interventions

Patients receive ADT SC or IM for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

Group III: Group I (radiation therapy)Experimental Treatment6 Interventions

Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gonadotropin-releasing Hormone Analog

2017

Completed Phase 2

~90

Radiation Therapy

2017

Completed Phase 3

~7250