Predictive Biomarker Testing for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Overseen ByJohn Floberg, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Wisconsin, Madison
Must be taking: Androgen deprivation
Disqualifiers: Metastatic disease, Prior pelvic radiation
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is for patients with high-risk prostate cancer. It uses a combination of radiation, internal radioactive seeds, and hormone therapy. The goal is to find new ways to predict how well these treatments will work using advanced imaging and genetic tests.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since participants are required to undergo specific cancer treatments, it's best to discuss your current medications with the trial team.
What data supports the effectiveness of this treatment for prostate cancer?
Research shows that combining external beam radiation therapy (EBRT) with a brachytherapy boost can reduce cancer recurrence in prostate cancer patients compared to using EBRT alone. However, the addition of androgen deprivation therapy (ADT) to this combination does not clearly improve overall survival, although it may help with biochemical control of the cancer.
12345Is the treatment generally safe for humans?
The combination of brachytherapy (internal radiation therapy) and external beam radiation therapy (EBRT) with androgen deprivation therapy (ADT) has been shown to increase toxicity in men with high-risk prostate cancer, although it improves biochemical control. This suggests that while effective, there may be safety concerns related to increased side effects.
25678How is the treatment for prostate cancer using androgen deprivation therapy, external beam radiation therapy, and prostate brachytherapy boost unique?
This treatment combines hormone therapy (to lower male hormones that fuel cancer growth), external radiation (to target cancer cells from outside the body), and internal radiation (brachytherapy) to deliver a high dose directly to the prostate, which may improve cancer control but can increase side effects compared to using external radiation and hormone therapy alone.
59101112Eligibility Criteria
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.Inclusion Criteria
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.
+4 more
Exclusion Criteria
I have had radiation therapy in the pelvic area before.
My scans show cancer has spread to other parts of my body.
Participant Groups
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.
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.
Androgen deprivation therapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Androgen deprivation therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇺🇸 Approved in United States as Androgen deprivation therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
🇨🇦 Approved in Canada as Androgen deprivation therapy for:
- Prostate cancer
- Metastatic prostate cancer
- Locally advanced prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
Loading ...
Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
References
Lack of Apparent Survival Benefit With Use of Androgen Deprivation Therapy in Patients With High-risk Prostate Cancer Receiving Combined External Beam Radiation Therapy and Brachytherapy. [2018]Although level 1 evidence has demonstrated a survival benefit from the addition of androgen deprivation therapy (ADT) to external beam radiation therapy (EBRT) for patients with high-risk prostate cancer, the benefits of ADT with combined EBRT and brachytherapy for high-risk patients are unclear. We examined the association between ADT and overall survival in a national cohort of high-risk patients treated with EBRT with or without brachytherapy.
Longitudinal assessment of changes in sexual function and bother in patients treated with external beam radiotherapy or brachytherapy, with and without neoadjuvant androgen ablation: data from CaPSURE. [2007]To evaluate the effects of external beam radiotherapy (EBRT), with or without brachytherapy (BT) boost or brachytherapy monotherapy with and without short-term androgen ablation (
Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study. [2021]External beam radiation therapy (EBRT) with brachytherapy boost reduces cancer recurrence in patients with prostate cancer compared with EBRT monotherapy. However, randomized controlled trials or large-scale observational studies have not compared brachytherapy boost types directly.
External beam radiation therapy and a low-dose-rate brachytherapy boost without or with androgen deprivation therapy for prostate cancer. [2022]To assess outcomes with external beam radiation therapy (EBRT) and a low-dose-rate (LDR) brachytherapy boost without or with androgen deprivation therapy (ADT) for prostate cancer.
Dramatically Polarized Opinion on the Role of Brachytherapy Boost in Management of High-risk Prostate Cancer: A Survey of North American Genitourinary Expert Radiation Oncologists. [2019]Three randomized clinical trials have established brachytherapy (BT) boost in combination with external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT) as superior to definitive EBRT and ADT alone in terms of biochemical control (but not overall survival) at the expense of increased toxicity in men with high-risk (HR) prostate cancer (PCa). The current view regarding these 2 treatment algorithms among North American genitourinary (GU) experts is not known.
Variations in patterns of concurrent androgen deprivation therapy use based on dose escalation with external beam radiotherapy vs. brachytherapy boost for prostate cancer. [2019]Retrospective data suggest less benefit from androgen deprivation therapy (ADT) in the setting of dose-escalated definitive radiation for prostate cancer, especially when a combination of external beam radiotherapy (EBRT) and brachytherapy approaches are used. This study aimed to test the hypothesis that patients with prostate cancer with intermediate- or high-risk disease undergoing extreme dose escalation with a brachytherapy boost are less likely to receive ADT.
Redefining high-risk prostate cancer based on distant metastases and mortality after high-dose radiotherapy with androgen deprivation therapy. [2020]Modern outcomes of high-dose external beam radiotherapy (EBRT) with androgen deprivation therapy (ADT) for high-risk (HR) prostate cancer are not well described.
No apparent benefit at 5 years from a course of neoadjuvant/concurrent androgen deprivation for patients with prostate cancer treated with a high total radiation dose. [2017]We examined the survival impact of a course of 6 months or less of adjuvant/concurrent androgen deprivation in patients with unfavorable prostate cancer treated to high radiation doses with external beam (EBRT) and a high dose rate (HDR) brachytherapy boost.
Posttreatment Prostate-Specific Antigen 6 Months After Radiation With Androgen Deprivation Therapy Predicts for Distant Metastasis-Free Survival and Prostate Cancer-Specific Mortality. [2017]To determine whether a 6-month posttreatment prostate-specific antigen (PSA) value in patients with prostate cancer (PCa) treated with concurrent androgen deprivation therapy (ADT) and external beam radiation therapy (EBRT) serves as an early predictor for biochemical relapse free survival (bRFS), distant metastasis-free survival (DMFS), and prostate cancer-specific mortality (PCSM).
Nadir PSA is a strong predictor of treatment outcome in intermediate and high risk localized prostate cancer patients treated by definitive external beam radiotherapy and androgen deprivation. [2018]The aim of this study is to investigate the effect of tumor characteristics and parameters of treatment response in predicting biochemical disease-free survival (BFS) for patients with intermediate or high risk prostate cancer treated by combined definitive external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT).
What is the optimal duration of androgen deprivation therapy in prostate cancer patients presenting with prostate-specific antigen levels > 20 ng/ml? [2007]To evaluate the optimal duration of androgen deprivation therapy (ADT) in patients with prostate cancer treated with external beam radiotherapy (EBRT), who present with PSA levels > 20 ng/mL.
Biochemical response to androgen deprivation therapy before external beam radiation therapy predicts long-term prostate cancer survival outcomes. [2014]To determine whether the response to neoadjuvant androgen deprivation therapy (ADT) defined by a decline in prostate-specific antigen (PSA) to nadir values is associated with improved survival outcomes after external beam radiation therapy (EBRT) for prostate cancer.