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Hormone Therapy

Predictive Biomarker Testing for Prostate Cancer

Phase < 1
Recruiting
Led By John Floberg, MD, PhD
Research Sponsored by University of Wisconsin, Madison
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 baseline, 3 months post therapy, every 6 months for 5 years
Awards & highlights

Study Summary

This trial is testing whether gene expression and imaging biomarkers can predict how well high-risk prostate cancer patients respond to different treatments.

Who is the study for?
This trial is for adults over 18 with high-risk prostate cancer, as defined by specific criteria like a PSA >20 or tumor stage ≥T3a. They must be able to undergo brachytherapy, have no prior pelvic radiation, and not have any metastatic disease. Participants should also be in good physical condition (ECOG 0-1) and free from other cancers for at least 5 years.Check my eligibility
What is being tested?
The study aims to identify imaging and genetic markers that predict how well patients respond to treatment. It involves external beam radiation therapy, a brachytherapy boost, androgen deprivation therapy (ADT), along with PET/MRI scans. Patients will participate for up to five years.See study design
What are the potential side effects?
Possible side effects include those related to radiation such as fatigue, skin changes, frequent urination or discomfort during urination; ADT can cause hot flashes, reduced sexual desire/functioning, weight gain; the PET/MRI procedure itself has minimal risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months post therapy, every 6 months for 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months post therapy, every 6 months for 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Imaging markers for mid-treatment response
Secondary outcome measures
Establish a correlation between MRI imaging response and pathologic response
Positron-Emission Tomography
Evaluate blood-based biomarkers for treatment response.
+2 more
Other outcome measures
Body Weight Changes
Prognostic significance of higher order radioman metrics

Trial Design

1Treatment groups
Experimental Treatment
Group I: EBRT + BTX + ADT, PET and MRIExperimental Treatment4 Interventions
Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External beam radiation therapy
2009
Completed Phase 3
~520
Androgen deprivation therapy
2021
Completed Phase 4
~260

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,839 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,912 Patients Enrolled for Prostate Cancer
John Floberg, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Androgen deprivation therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05477823 — Phase < 1
Prostate Cancer Research Study Groups: EBRT + BTX + ADT, PET and MRI
Prostate Cancer Clinical Trial 2023: Androgen deprivation therapy Highlights & Side Effects. Trial Name: NCT05477823 — Phase < 1
Androgen deprivation therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05477823 — Phase < 1

Frequently Asked Questions

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

Does this research endeavor still accept volunteers?

"Indeed, the information posted on clinicaltrials.gov confirms that this trial is actively seeking enrolment. It was first announced on December 1st 2022 and updated recently on November 30th 2022 with a target of recruiting 30 participants from one site."

Answered by AI

How many participants are involved in this medical experiment?

"Affirmative. Clinicaltrials.gov corroborates that this research is recruiting participants, and the trial was initially posted on December 1st 2022 before its last update on November 30th 2022. The experiment seeks to enrol 30 individuals from one location."

Answered by AI
~20 spots leftby Aug 2027