An observational study in Prostate Cancer, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Cancer Institute (NCI) · Observational
Background:
Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. These changes might lead to the development and progression of prostate cancer. Researchers think the study could lead to new treatments.
Objective:
To understand the changes in cells and genes that lead to the development and progression of prostate cancer. This could lead to new treatments.
Eligibility:
Men ages 18 and older who have or are suspected to have prostate cancer
Design:
Participants will be screened with physical exam and medical history.
Participants will send tissue blocks of their tumor, if possible. If not, they will provide unstained slides of tumor tissue.
Participants may provide samples of blood, urine, saliva, and prostate secretions.
Participants may have imaging tests. They will lie in a machine that takes pictures of their body. These tests include:
MRI of the prostate
CT of the abdomen and pelvis
Chest x-ray
Participants may need a biopsy or surgery for treatment of their cancer. If so, researchers will collect tissue.
Participants may answer questions about their prostate cancer and quality of life.
Participants may have follow-up visits or other treatments. They may have follow-up phone calls every few months.
...
Background:
Objective:
Collect blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue from patients with known or suspected prostate cancer for the purpose of elucidating the molecular mechanisms of carcinogenesis in prostate cancer and ultimately, identifying novel therapeutic targets.
Eligibility:
- Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or followup/surveillance for their neoplasm.
Design:
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults with biopsy-proven or suspected prostate cancer who require diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults (greater than or equal to 18 years of age) with -proven or suspected prostate cancer (elevated PSA abnormal digital rectal exam (DRE) abnormal prostate MRI, or family history) who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.
EXCLUSION CRITERIA:
1. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (= 18 years of age) with biopsy-proven or suspected prostate cancer
Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer
Collection of blood, urine, saliva, expressed prostatic secretions, and benign and malignant tissue
Time frame: Ongoing
prostate cancer cell lines
Develop stable prostate cancer cell lines from procured tissue when feasible
Time frame: ongoing
Natural history of prostate cancer
Collect detailed history, pathologic data, perioperative findings, and treatment data to better characterize the natural and clinical histories of prostate cancer when feasible
Time frame: ongoing
Molecular profiling
whole genomic sequence characterizations, identification of specific mutations or single nucleotide polymorphisms (SNPs), comparative genomic hybridization, messenger and microRNA sequencing and expression, RNA Seq, DNA methylation (epigenetics), DNA copy number, and expression profiling
Time frame: ongoing
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
Started Dec 2015 (actual). Primary completion is estimated for Jan 2036, 240 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 240 months is above that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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