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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months post therapy, every 6 months for 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months post therapy, every 6 months for 5 years
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 moreOther 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
1,183 Previous Clinical Trials
3,167,674 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,936 Patients Enrolled for Prostate Cancer
John Floberg, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy in the pelvic area before.My scans show cancer has spread to other parts of my body.I am fully active or can carry out light work.I am 18 years old or older.My prostate cancer is confirmed by a tissue examination.My cancer is considered high-risk with a PSA over 20, or it's advanced.I have agreed to undergo specific radiation therapy and hormone therapy for 6-36 months before joining the study.I have been cancer-free for at least 5 years if I had another cancer type.I can have a specific prostate cancer treatment because my prostate is small enough, I haven't had certain prostate surgeries, and my symptoms are manageable.
Research Study Groups:
This trial has the following groups:- Group 1: EBRT + BTX + ADT, PET and MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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