Biopsy Collection for Men Undergoing Brachytherapy for Prostate Cancer

NCT04243473 | Withdrawn DMC

• 1 other identifier: IRB00209927
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Brachytherapy

Outcome Measures

Primary Outcomes (1)

• Acquisition and banking of biospecimen collected from men undergoing brachytherapy

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Newly diagnosed prostate cancer within the past 12 months:
• The patient has decided to undergo brachytherapy as treatment modality for his prostate cancer.
• Suitable volume of disease for biopsy, defined as one or more of the following:
• Identifiable lesions of greater or equal to one
• Clinically palpable disease corresponding to (ipsilateral to) any involved core on biopsy OR
• ≥50% of biopsy cores involved with cancer
• 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.
• Males 18 years of age or older
• Signed study-specific consent form prior to registration

You may not qualify if:

• 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.
• Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Related Publications (6)

• Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

  PMID: 12126818 BACKGROUND

• D'Amico AV, Moul J, Carroll PR, Sun L, Lubeck D, Chen MH. Cancer-specific mortality after surgery or radiation for patients with clinically localized prostate cancer managed during the prostate-specific antigen era. J Clin Oncol. 2003 Jun 1;21(11):2163-72. doi: 10.1200/JCO.2003.01.075.

  PMID: 12775742 BACKGROUND

• Kishan AU, Cook RR, Ciezki JP, Ross AE, Pomerantz MM, Nguyen PL, Shaikh T, Tran PT, Sandler KA, Stock RG, Merrick GS, Demanes DJ, Spratt DE, Abu-Isa EI, Wedde TB, Lilleby W, Krauss DJ, Shaw GK, Alam R, Reddy CA, Stephenson AJ, Klein EA, Song DY, Tosoian JJ, Hegde JV, Yoo SM, Fiano R, D'Amico AV, Nickols NG, Aronson WJ, Sadeghi A, Greco S, Deville C, McNutt T, DeWeese TL, Reiter RE, Said JW, Steinberg ML, Horwitz EM, Kupelian PA, King CR. Radical Prostatectomy, External Beam Radiotherapy, or External Beam Radiotherapy With Brachytherapy Boost and Disease Progression and Mortality in Patients With Gleason Score 9-10 Prostate Cancer. JAMA. 2018 Mar 6;319(9):896-905. doi: 10.1001/jama.2018.0587.

  PMID: 29509865 BACKGROUND

• Potters L, Morgenstern C, Calugaru E, Fearn P, Jassal A, Presser J, Mullen E. 12-year outcomes following permanent prostate brachytherapy in patients with clinically localized prostate cancer. J Urol. 2008 May;179(5 Suppl):S20-4. doi: 10.1016/j.juro.2008.03.133.

  PMID: 18405743 BACKGROUND

• Radwan N, Phillips R, Ross A, Rowe SP, Gorin MA, Antonarakis ES, Deville C, Greco S, Denmeade S, Paller C, Song DY, Diehn M, Wang H, Carducci M, Pienta KJ, Pomper MG, DeWeese TL, Dicker A, Eisenberger M, Tran PT. A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE). BMC Cancer. 2017 Jun 29;17(1):453. doi: 10.1186/s12885-017-3455-6.

  PMID: 28662647 BACKGROUND

• Otake S, Goto T. Stereotactic Radiotherapy for Oligometastasis. Cancers (Basel). 2019 Jan 23;11(2):133. doi: 10.3390/cancers11020133.

  PMID: 30678111 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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 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.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniel Song, MD

  Johns Hopkins SKCCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 28, 2020
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: January 19, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)