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Hormone Therapy
Group III (ADT, radiation therapy, abiraterone acetate) for Prostate Adenocarcinoma
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hormonal domain scores
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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Abiraterone Acetate
2015
Completed Phase 4
~1880
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,223 Previous Clinical Trials
3,769,244 Total Patients Enrolled
Carlos E. Vargas, M.D.Principal InvestigatorMayo Clinic
5 Previous Clinical Trials
365 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there ongoing efforts to actively enroll participants for this research study?
"As per information available on clinicaltrials.gov, this current medical investigation is not actively seeking participants. Originally shared with the public on April 22nd, 2024, it was last revised on April 12th of the same year. Despite its inactive status for enrollment, there are currently an additional 2047 ongoing trials in search of eligible candidates."
Answered by AI
Has the combination of Androgen Deprivation Therapy and radiation therapy in Group II received approval from the Food and Drug Administration?
"In this Phase 2 trial, Group II treatment involving androgen deprivation therapy (ADT) with radiation therapy has been deemed moderately safe by our team at Power, earning a safety rating of 2 due to existing safety data but lacking efficacy evidence."
Answered by AI
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