Suspended

Focal Therapy for the Treatment of Organ Confined Prostate Cancer

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What is being tested

Brachytherapy

Radiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 45 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore
Last updated: May 11, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Prostate cancer is a lethal disease for ~11% of the men who are diagnosed with it. Early detection of prostate cancer using the PSA blood test can detect cancer a decade or more before it would have been found on a prostate examination. Men who are diagnosed at an older age (>75) may not benefit from aggressive treatment because many will not live long enough for the prostate cancer to kill them. Men who are diagnosed at a young age will be more likely to benefit from treatment from prostate cancer but they will have a very long time to live with some of the side effects of treatment. Patients with low-risk prostate cancer, which is located in only one area or on one side of the prostate, may benefit from treatment of that one area instead of treating the entire prostate. This is similar to the lumpectomy of breast cancer which removes only the tumor instead of removing the entire breast. This study will look at the short-term side-effects and the long-term success of performing focal treatment of prostate cancer. Patients who are newly diagnosed with prostate cancer or who are already diagnosed and on an active surveillance protocol will be considered eligible for consideration of focal therapy. Patients deemed eligible will be offered inclusion in the study. There will only be a treatment group, no controls or placebo.

Principal SponsorUniversity of Maryland, Baltimore
Last updated: May 11, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

Criteria

5 inclusion criteria required to participate
Age > 44

Low risk Prostate Cancer (PSA < 10, Gleason 6)

Low-volume intermediate risk prostate cancer (PSA < 15, Gleason 3+4=7)

Male

Show More Criteria

5 exclusion criteria prevent from participating
Locally advanced disease either by digital rectal exam or MRI

Metastatic Disease

PSA > 10 (for age < 75)

PSA > 15

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Maryland School of Medicine

Baltimore, United StatesOpen University of Maryland School of Medicine in Google Maps
SuspendedOne Study Center