Prostate CancerNCT04243473
Biopsy Collection for Men Undergoing Brachytherapy for Prostate Cancer
An observational study of Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to 19 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- Brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years post-implant at confirmatory biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startJan 2026 (estimated)
- Primary completionJan 2026 (estimated)
- Study completion19 Jan 2026
Why it stopped: The study team decided to not move forward with enrolling patients because funding was not identified to support the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Song, MD, Principal investigator, Johns Hopkins SKCCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243473
- Sponsor's protocol ID
- IRB00209927
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2020
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12126818D'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.
PubMed 12775742Kishan 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.
PubMed 29509865Potters 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.
PubMed 18405743Radwan 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.
PubMed 28662647Otake S, Goto T. Stereotactic Radiotherapy for Oligometastasis. Cancers (Basel). 2019 Jan 23;11(2):133. doi: 10.3390/cancers11020133.
PubMed 30678111
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Tissue Biopsy Collection for Men Undergoing Brachytherapy for Treatment of Localized or Locally Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT04243473
- Acronym / sponsor ID
- IRB00209927
- Conditions
- Prostate Cancer
- Keywords
- Brachytherapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study team decided to not move forward with enrolling patients because funding was not identified to support the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 12126818Bolla 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.
- Background: PubMed 12775742D'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.
- Background: PubMed 29509865Kishan 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.
- Background: PubMed 18405743Potters 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.
- Background: PubMed 28662647Radwan 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.
- Background: PubMed 30678111Otake S, Goto T. Stereotactic Radiotherapy for Oligometastasis. Cancers (Basel). 2019 Jan 23;11(2):133. doi: 10.3390/cancers11020133.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Song, MD principal investigator
Johns Hopkins SKCCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition and banking of biospecimen collected from men undergoing brachytherapy (time frame: Up to 2 years post-implant at confirmatory biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243473, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.