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New scan could spot dangerous prostate cancer without needle biopsy

NCT ID NCT03471650

Diagnosis Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special PET/CT scan using a radioactive tracer called 18F-DCFPyL can better detect aggressive prostate cancer in men with elevated PSA levels. About 150 men with PSA between 2-10 ng/mL and no prior biopsy will receive the scan before their standard biopsy. The goal is to see if the scan is more accurate than PSA alone at identifying cancers that need treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
18F-DCFPyL (a radioactive tracer for PET/CT imaging)
What this could lead to
If successful, this scan could become a more accurate, non-invasive way to detect aggressive prostate cancer early, reducing unnecessary biopsies.
What could go wrong
This is a single-center, phase II study with only 150 men, so results may not apply to everyone. The scan may not be better than current methods and could still miss some cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥18 years of age * PSA of 2-10 ng/mL * Clinical stage T1c-T2a on digital rectal exam * Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care * Willingness to sign informed consent and comply with all protocol requirements Exclusion Criteria: * History of prior prostate biopsy * Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT * Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT * Administered oral contrast medium ≤120 hours prior to the date of study PET/CT * Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • SKCCC

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.