Glow-in-the-Dark antibody could help surgeons spot prostate cancer
NCT ID NCT02048150
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
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36 to 74 years
- Sex
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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 Hide 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.
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- Can a One-Week radiation course match four weeks for prostate cancer?
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- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains