What is the mechanism of action of this treatment?

External Beam Radiation Therapy (EBRT) uses high-energy rays to target and destroy cancer cells from outside the body, minimizing damage to surrounding healthy tissue. Brachytherapy (BTX) involves placing radioactive material directly inside or near the tumor, providing a high radiation dose to the cancer cells while sparing nearby healthy tissue. Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that can stimulate the growth of prostate cancer cells, thereby slowing the progression of the disease. These treatments are crucial for prostate cancer patients as they offer targeted approaches to control and potentially eradicate cancer while aiming to preserve quality of life by minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as External Beam Radiation Therapy (EBRT), Brachytherapy (BTX), and Androgen Deprivation Therapy (ADT), have distinct side effects. EBRT can cause acute gastrointestinal toxicity, urinary symptoms, and fatigue, with a potential for late toxicity affecting the bowel and bladder. Brachytherapy may lead to urinary incontinence, irritation, and erectile dysfunction. ADT is associated with side effects like bone loss, increased risk of fractures, hot flashes, decreased libido, and potential cardiovascular issues. Combining these therapies can amplify these side effects, necessitating careful management and monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that align with the therapies being studied in the trial involving EBRT, BTX, and ADT. External Beam Radiation Therapy (EBRT) and Brachytherapy (BTX) are established radiation treatments that have been widely used and refined over the years. Androgen Deprivation Therapy (ADT) includes drugs such as leuprolide (Lupron), goserelin (Zoladex), and degarelix (Firmagon), which reduce androgen levels to slow the growth of prostate cancer. These therapies are often used in combination to enhance treatment efficacy and manage high-risk prostate cancer.

What other types of research exist?

Promising novel alternatives to EBRT+BTX+ADT for prostate cancer patients include: 1) Enzalutamide combined with Androgen Deprivation Therapy (ADT), which has shown improved survival rates in metastatic hormone-sensitive prostate cancer. 2) Abiraterone combined with ADT, which is another effective option for high-risk/high-volume disease. 3) Stereotactic Body Radiation Therapy (SBRT), which offers a more accelerated and precise radiation treatment. 4) Immunotherapy approaches, such as checkpoint inhibitors, are being explored for their potential to enhance the body's immune response against prostate cancer. These alternatives are supported by recent clinical trials and studies, indicating their potential efficacy and safety.

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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

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

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

External Beam Radiation Therapy (EBRT) uses high-energy rays to target and destroy cancer cells from outside the body, minimizing damage to surrounding healthy tissue. Brachytherapy (BTX) involves placing radioactive material directly inside or near the tumor, providing a high radiation dose to the cancer cells while sparing nearby healthy tissue. Androgen Deprivation Therapy (ADT) reduces androgen levels, which are hormones that can stimulate the growth of prostate cancer cells, thereby slowing the progression of the disease. These treatments are crucial for prostate cancer patients as they offer targeted approaches to control and potentially eradicate cancer while aiming to preserve quality of life by minimizing side effects.

The effectiveness and side effects of conformal external beam radiotherapy combined with high-dose-rate brachytherapy boost compared to conformal external beam radiotherapy alone in patients with prostate cancer.Lymph node-positive prostate cancer: evaluation of the results of the combination of androgen deprivation therapy and radiation therapy.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,198 Previous Clinical Trials

3,162,234 Total Patients Enrolled

33 Trials studying Prostate Cancer

8,913 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

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