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Laser and Light-Sensitive drug aim to zap prostate cancer without surgery

NCT ID NCT06807359

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new treatment for men with localized prostate cancer. It uses a light-sensitive drug called verteporfin, which is injected into the bloodstream and then activated by laser light delivered through thin fibers placed into the prostate. The goal is to destroy cancer cells while minimizing damage to healthy tissue. The study will enroll 43 participants and follow them for up to 3 years to check safety and effectiveness.

What this could mean

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

Active substance
verteporfin (a light-activated drug)
What this could lead to
If successful, this could offer a less invasive treatment option for localized prostate cancer that targets tumors precisely and reduces side effects compared to surgery or radiation.
What could go wrong
This is an early-phase trial with only 43 participants, so results may not apply to all patients. The treatment requires general anesthesia and carries risks like damage to nearby tissues or side effects from the drug.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 43 people

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

Started

Jan 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Subjects ≥ 18 years. 2. Histologically confirmed organ-confined adenocarcinoma of the prostate cancer diagnosed within the last 9 months. Including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months. a. This prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon. 3. Gleason Score 7 (3+4 or 4+3). 4. PSA ≤ 15 ng/mL. 5. Lesion volume on mpMRI \< 1.5 cm3. 6. Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer. \- Bone scan is optional if PSA \< 10 ng/mL. 7. Treatment target volume \<50 cm3 defined by TRUS or MRI. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Expected survival ≥ 36 months. 10. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3. 11. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl. 12. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal. 13. Signed Informed Consent. Exclusion Criteria: 1. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease. 2. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI 3. Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy) 4. High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as \>1 core of GG1 with a linear amount of carcinoma \>6mm. 5. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate. 6. Prior treatment with any form of brachytherapy. 7. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer. 8. Prior or current bleeding diathesis. 9. Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site. 10. Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment. 11. Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). 12. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator. 13. Contraindication for photosensitizer including: 1. Porphyria or other diseases exacerbated by light. 2. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients. 3. Known allergies to porphyrins. 14. On-going therapy with a photosensitizing agent. 15. Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study. 16. Contraindication for MRI/Gadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2), or previous contrast reactions. 17. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Klinik für Urologie, Universitätsklinikum Köln

    RECRUITING

    Cologne, 50937, Germany

  • Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock

    RECRUITING

    Rostock, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

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