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Glow-in-the-Dark antibody could help surgeons spot prostate cancer

NCT ID NCT02048150

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a fluorescent antibody that attaches to prostate cancer cells. Seven men with moderate- to high-risk prostate cancer received the antibody before robotic prostate removal surgery. The goal was to see if the glowing antibody could help surgeons identify cancerous tissue during the operation.

What this could mean

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

Active substance
anti-PSMA monoclonal antibody MDX1201-A488
What this could lead to
If it works, this could help surgeons see prostate cancer more clearly during surgery, potentially leading to more complete tumor removal.
What could go wrong
This is a very early, small trial with only 7 people, so results may not apply widely. The imaging technique may not improve outcomes or could miss some cancer cells.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

Mar 2015

Finished

Feb 2023

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

36 to 74 years

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: * Histologically confirmed adenocarcinoma of the prostate; patients with small cell, neuroendocrine, and transitional cell carcinomas are not eligible * Patients being considered for RALP and pelvic lymphadenectomy with life expectancy greater than 10 years as determined by treating physician * Patients with moderate to high-risk disease as defined by D' Amico risk stratification and having at least one of the following: * Prostate-specific antigen (PSA) level \> 10 ng/ml * Gleason score \>= 7 * Clinical stage \>= T2c * Any performance status on the Eastern Cooperative Oncology Group (ECOG) * Men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation * Bone scan without evidence of skeletal metastases * Skeletal x-ray film or MRI confirmation of absent skeletal metastases if bone scan findings are equivocal * 3Tesla (T) multiparametric MRI of the prostate performed at City of Hope (COH) within 6 week time period prior to surgery; MRI without evidence of bladder neck involvement, rectal wall involvement, or pelvic lymphadenopathy with no nodes \> 1 cm * White blood cell (WBC) within normal limits * Hemoglobin (hgb) \> 10 G/dL * Platelet count (PLT) \> 100 K/uL * Creatinine clearance within normal limits * Serum glutamic oxaloacetic transaminase (SGOT) \< 1.5 x upper limit of normal (ULN) * Serum glutamate pyruvate transaminase (SGPT) \< 1.5 x ULN * Bilirubin \< 1.5 x ULN * All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * Prior treatment of prostate cancer including brachytherapy, radiation therapy, cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapy * Prior pelvic surgery or radiation * Urinary incontinence requiring condom catheter use or \>= 1 pad/day * Prior anti-incontinence surgery * Use of neoadjuvant hormonal manipulation * History of active co-existing non-prostatic malignancies except basal cell skin cancer or squamous cell skin cancer * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

More trials for these conditions

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