Prostate CancerNCT07222436
Circulating Tumor DNA in High Risk Localized Prostate Cancer
An observational study of Prostate Cancer, run by University of Pittsburgh at 1 site in United States.
Trial summary
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high risk localized prostate cancer prior to prostatectomy.
Who may be able to join
- Must have histologically confirmed prostate cancer.
- Age ≥ 18 years.
- ECOG performance status of 0-1.
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Willing to provide serial blood samples for the study.
- Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens.
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- Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:
- o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20
- Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate.
- Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following:
- Localized prostate adenocarcinoma on active surveillance
- Biochemically-recurrent prostate adenocarcinoma after definitive local therapy
- Hormone-sensitive, metastatic prostate adenocarcinoma
- Metastatic CRPC
Who cannot join
- History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
- Receiving androgen deprivation or other systemic therapy for prostate cancer.
- Medical condition or social situation that may preclude adherence to the protocol.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Brieanna Marino, MS, 4126478258, rowlesbm@upmc.edu
Leonard J Appleman, MD
About this study
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Read the detailed description
The Vogelstein lab has developed a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay, employing DNA sequences derived from prostatectomy specimens. The abundance and molecular characteristics of ctDNA will be evaluated for a pilot group of 12-24 patients using an adaptive statistical design.
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, ctDNA
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA detection
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
Measured: Up to 2 years
Secondary outcomes (4)
ctDNA abundance
Quantification of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
Measured: Up to 2 years
serum PSA recurrence
The detection of prostate-specific antigen (PSA) levels that rise after initial treatment for prostate cancer. This can indicate a regrowth of cancer cells or a biochemical recurrence, meaning that while the cancer may not be visible on imaging, it is still present in the body.
Measured: At 6 weeks post-operative
serum PSA recurrence
The detection of prostate-specific antigen (PSA) levels that rise after initial treatment for prostate cancer. This can indicate a regrowth of cancer cells or a biochemical recurrence, meaning that while the cancer may not be visible on imaging, it is still present in the body.
Measured: At 6 months post-operative
serum PSA recurrence
The detection of prostate-specific antigen (PSA) levels that rise after initial treatment for prostate cancer. This can indicate a regrowth of cancer cells or a biochemical recurrence, meaning that while the cancer may not be visible on imaging, it is still present in the body.
Measured: At 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start23 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Beckwith Institute
- Responsible party
- Principal investigator, Leonard Appleman, University of Pittsburgh
- Investigators
- Leonard J Appleman, MD, PhD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222436
- Sponsor's protocol ID
- HCC 25-054
- Status last verified
- Oct 2025
- First submitted
- 27 Oct 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA in High Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07222436
- Acronym / sponsor ID
- HCC 25-054
- Conditions
- Prostate Cancer
- Keywords
- prostatectomy, ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Beckwith Institute
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Oct 2025 (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.
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Detailed description
The Vogelstein lab has developed a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay, employing DNA sequences derived from prostatectomy specimens. The abundance and molecular characteristics of ctDNA will be evaluated for a pilot group of 12-24 patients using an adaptive statistical design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high risk localized prostate cancer prior to prostatectomy.
Key inclusion criteria (14 listed)
- Must have histologically confirmed prostate cancer.
- Age ≥ 18 years.
- ECOG performance status of 0-1.
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Willing to provide serial blood samples for the study.
Key exclusion criteria (4 listed)
- History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
- Receiving androgen deprivation or other systemic therapy for prostate cancer.
- Medical condition or social situation that may preclude adherence to the protocol.
- -
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
ctDNA detection
Time frame: Up to 2 years
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
4 secondary outcomes
ctDNA abundance
Time frame: Up to 2 years
serum PSA recurrence
Time frame: At 6 weeks post-operative
serum PSA recurrence
Time frame: At 6 months post-operative
serum PSA recurrence
Time frame: At 12 months post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Leonard J Appleman, MD, PhD principal investigator
UPMC Hillman Cancer Center
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 University of Pittsburgh 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 14 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brieanna Marino, MS (4126478258, rowlesbm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA detection (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2025.