An observational study in Prostatic Neoplasms, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to male participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by National Cancer Institute (NCI) · Observational
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Among 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI) — 26 open to participants now, 43 under way, none of them phase 3. Prostatic Neoplasms · National Cancer Institute (NCI).
Among the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI), this one is the 19th largest by planned enrollment of the 30 observational ones that give a count, is one of 9 that started in 2019, is one of 30 observational ones, reaches primary completion later than 26 of the 37 other live ones, and was the 166th registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →26 of the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI) are open now, in 2 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
National Cancer Institute (NCI) · Sites in United States
Ages 45–75 · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 30 Years to 75 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
202 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 61 · Phase 2 116 · Phase 3 5
First in 1988; this study’s year is marked. 9 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Median enrollment 41 across the 166 interventional studies, 1,016 across the 30 observational. Of the 154 that completed or were terminated, 84 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
11 of the studies in Prostatic Neoplasms by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05588128National Cancer Institute (NCI)Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL | 2026-12-31 |
| NCT04633252National Cancer Institute (NCI)A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer | 2026-12-31 |
| NCT05828082National Cancer Institute (NCI)Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer | 2027-01-01 |
| NCT01834001National Cancer Institute (NCI)Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy | 2027-02-25 |
| NCT03866382National Cancer Institute (NCI)Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors | 2027-02-28 |
Add all 11 to your calendar (.ics) → With an account.
Among the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI), from their registry updates:
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Background:
Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer.
Objectives:
To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer.
Eligibility:
Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer.
Design:
Background:
Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.
Prostate cancer has substantial inherited predisposition and certain genetic variants that are associated with an increased risk of prostate cancer.
An evolving approach to prostate cancer screening is to target populations at risk of developing prostate cancer based on their genetic predisposition.
Objective:
To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at risk for developing prostate cancer.
Eligibility:
Males between ages 30-75 years old.
Documented germline pathogenic or likely pathogenic variants in prostate cancer-related risk gene: BRCA 1 and 2, DNA Mismatch Repair (MMR) genes associated with Lynch syndrome (MLH1, MSH2, MSH6, PMS2, and EPCAM), HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).
Must be able and willing to provide informed consent.
Design:
Up to 500 subjects will be enrolled.
Participants will undergo sampling of blood for prostate-specific antigen. Based on these results and age, participants will be considered for biopsy and/or continued monitoring if feasible upon clinical discretion.
Participants will undergo a baseline MRI evaluation with follow-up scans every 2 years as clinically indicated.
Following initial evaluation, participants will be followed as clinically indicated, usually at 12 month intervals, to determine their PSA level, prostate cancer treatment (if relevant) and/or disease/survival status until death.
Men with a documented germline variant in prostate cancer risk-related gene from a CLIA certified laboratory
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.
Exclusion Criteria:
Known to MRI:
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes
Natural history of high genetic risk for prostate cancer
To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer
Time frame: one year
mpMRI feasibility
test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer
Time frame: baseline and every two years until death or when criteria for removal from study is met
role of mpMRI
role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression
Time frame: baseline and every two years until death or when criteria for removal from study is met
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 Mar 2019 (actual). Primary completion is estimated for Jan 2029, 117 months after the start.
Of 542 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 30 and three quarters within 162. This study's planned 117 months is above that.
Counting every sponsor, half of 651 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 ↗
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National Cancer Institute (NCI) →