Biopsy Collection for Men Undergoing Brachytherapy for Prostate Cancer

March 2, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Prostate Tissue Biopsy Collection for Men Undergoing Brachytherapy for Treatment of Localized or Locally Advanced Prostate Cancer

The primary goal of this tissue collection protocol is to establish a framework for the acquisition and banking of biospecimen collected from men undergoing brachytherapy. Biopsies of the prostate is an invasive procedure; however, in this tissue collection protocol, biopsies are acquired intraoperatively while patients are prepped for brachytherapy seed placement, thus minimizing the inconvenience of the biopsy procedure for patients. The utility of these biopsies will provide a valuable resource for molecular assessments.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Many patients with metastatic prostate cancer who succumb to the disease are initially diagnosed with localized prostate cancer, where treatment has the potential to be curative. For men initially diagnosed with high risk or locally advanced prostate cancer, nearly 50% develop recurrence after primary therapy and can eventually progress to life-threatening metastatic disease. Combined androgen deprivation therapy (ADT) with ionizing radiation (IR) is the current mainstay of therapy for such men with high-risk prostate cancer. While it is likely that undetected, microscopic disseminated disease leads to the inability to cure in some men, there is also emerging evidence that escalating local therapy may still have benefit. It has been reported that metastasis-free survival and overall survival were significantly improved in men with high-risk localized prostate cancer treated with external beam radiotherapy (EBRT) with brachytherapy boost compared to men treated with EBRT alone, or with radical prostatectomy. The observation that enhanced IR-based local therapy could improve outcomes supports the notion that it is not microscopic systemic disease alone that leads to treatment failures of high-risk prostate cancer, but that more aggressive local management could still play a significant role.

A key question in the management of high risk prostate cancer is how can the investigators predict whether a patient with local or metastatic prostate cancer will have complete response with current IR-based therapy paradigms, or if patients would benefit from more aggressive dosing regimens despite a potential for increased adverse effects. A major limitation to developing effective strategies for predicting treatment response to conventional vs. more aggressive dosing regiments has been a paucity of tissues from patients undergoing radiation therapy, including at baseline and during follow up, as well as a lack of the molecular, cell biological, and biochemical states of the cancer and microenvironmental cells in such tissues. The availability of such tissues and data can accelerate the discovery process of identifying novel biomarkers and therapeutic strategies for patients with prostate cancer.

Thus, a more comprehensive understanding of the tissue microenvironment at base line and following radiation therapy may inform improved strategies in radiation dosing, as well as complementary neoadjuvant and adjuvant treatments to achieve complete response in organ-confined disease in the future. Such an understanding of the tissue and biological response of prostate cancer to radiotherapy may also provide insights to enhance IR-based therapy of metastatic and oligometastatic disease, for both palliative and perhaps life-prolonging intent.

The primary goal of this tissue collection protocol is to establish a framework for the acquisition and banking of biospecimen collected from men undergoing brachytherapy. Biopsy of the prostate is an invasive procedure; however, in this tissue collection protocol, biopsies are acquired intraoperatively while patients are prepped for brachytherapy seed placement, thus minimizing the discomfort as well as the inconvenience of the biopsy procedure for patients. A subset of these patients will choose to have a 2 year confirmatory biopsy to detect the absence or persistence of disease. Biopsy cores collected 2 years post-IR therapy will also be included in the investigators' correlative studies. These biopsies will provide a valuable resource for molecular and pathological assessments. To extract the maximal amount of information from these biopsy specimens, the investigators will utilize comprehensive genomic, pathological, and biochemical analyses including DNA-seq, RNA-seq, methylome analysis, single cell sequencing, immunohistochemistry (IHC)/immunofluorescence (IF). The investigators will also collect and maintain a database of the clinicopathological parameters and follow up information for these specimens. The biobank will thus represent a bank of tissues as well as the correlative measurements on those tissues.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population will be patients for whom the treatment plan includes brachytherapy for localized or locally advanced adenocarcinoma of the prostate who are seen in consultation at the Department of Radiation Oncology and Molecular Radiation Sciences.

Description

Inclusion Criteria:

  1. Newly diagnosed prostate cancer within the past 12 months:
  2. The patient has decided to undergo brachytherapy as treatment modality for his prostate cancer.

  3. Suitable volume of disease for biopsy, defined as one or more of the following:

    1. Identifiable lesions of greater or equal to one
    2. Clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy OR
    3. ≥50% of biopsy cores involved with cancer
  4. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
  5. Males 18 years of age or older
  6. Signed study-specific consent form prior to registration

Exclusion Criteria:

  1. Prior history of any other malignancy which was either newly diagnosed or recurred (following prior curative treatment) within last 2 years, other than non-melanoma skin carcinoma.
  2. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prostate Biopsy, Urine sample and Blood sample
For purposes of exploratory analyses, blood (whole blood, serum, plasma) and urine samples will be collected pre-IR treatment, 1-month post-implant, 6 month follow-up and 2 years follow-up. Patients will be asked to opt-in on the consent form specifically for the 2-year biopsy, otherwise they have the choice to opt out.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition and banking of biospecimen collected from men undergoing brachytherapy
Time Frame: Up to 2 years post-implant at confirmatory biopsy
Prostate biopsies and biospecimen will be sequenced to characterize the baseline and post-treatment transcriptional and genomic/epigenomic changes of the prostate tissue microenvironment in response to IR-based therapy. We will also collect and maintain clinicopathological parameters including baseline prostate-specific antigen (PSA), stage, grade, demographic information, and follow up data including biochemical/radiological recurrence, and other molecular attributes. We will also obtain non-invasive and minimally invasive blood and urine specimens for banking and potential correlative genomic and biochemical measurements.
Up to 2 years post-implant at confirmatory biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Daniel Song, MD, Johns Hopkins SKCCC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2026

Study Completion (Actual)

January 19, 2026

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00209927

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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