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Vascular-Disrupting Agent

TOOKAD Soluble for Prostate Cancer

Phase 2
Waitlist Available
Led By Jonathan Coleman, MD
Research Sponsored by Steba Biotech S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate cancer stage up to cT2a - N0/Nx - M0/Mx
Men over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, 12, 24, 36, 48, 60
Awards & highlights

Study Summary

This trial will look at men with localized prostate cancer who will receive TOOKAD® Soluble VTP under general anesthesia. The goal is to see if there are any Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland 12 months after treatment.

Who is the study for?
Men over 18 with localized prostate cancer, Gleason score of 3+4 in limited areas, and a PSA level ≤10 ng/mL. They must have had recent MRI and biopsy results within the last 6 months. Participants need to agree to use effective contraception for 90 days post-treatment.Check my eligibility
What is being tested?
The trial is testing TOOKAD Soluble VTP treatment's effectiveness on men with intermediate-risk prostate cancer. It's an open-label study where all participants receive the drug under general anesthesia and are followed up for five years.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with general anesthesia, tissue reactions at the treatment site, urinary issues due to prostate manipulation, or photosensitivity-related skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is in an early stage and hasn't spread to lymph nodes or other parts.
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I am a man over 18 years old.
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My prostate size is between 25 mL and 70 mL.
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My prostate cancer has a Gleason score of 3+3 in less than half of any sample.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, 12, 24, 36, 48, 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, 12, 24, 36, 48, 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Negative Biopsy for Gleason Grade 4 or 5 Prostate Cancer on 12-month Post-treatment
Secondary outcome measures
Absence of Any Gleason 4 or 5 in the Treated Lobe
Absence of Any Prostate Cancer on Biopsy
Absence of Any Prostate Cancer on Biopsy in the Treated Lobe
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TOOKAD Soluble 4 mg/kgExperimental Treatment1 Intervention
TOOKAD® Soluble VTP treatment consist of the combination of a single, 10-minute IV infusion of TOOKAD® Soluble at the dose of 4 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.

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Who is running the clinical trial?

Steba Biotech S.A.Lead Sponsor
16 Previous Clinical Trials
1,253 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,026 Patients Enrolled for Prostate Cancer
Jonathan Coleman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
518 Total Patients Enrolled
1 Trials studying Prostate Cancer
121 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Clinical Trial 2023: TOOKAD Soluble Highlights & Side Effects. Trial Name: NCT03315754 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to register for this investigation?

"The trial, which has not been updated since May 3rd 2022 according to clinicaltrials.gov, is no longer recruiting participants. Nonetheless, there are currently 1254 different studies actively looking for people to take part in them."

Answered by AI

Is the TOOKAD Soluble 4 mg/kg formula officially sanctioned by the FDA?

"Due to the fact that this is a Phase 2 medical trial, which indicates there may be some data suggesting safety but no data proving efficacy, our team at Power has assigned TOOKAD Soluble 4 mg/kg a score of two."

Answered by AI

How many participants are contributing to the outcome of this experiment?

"Unfortunately, at this time, recruitment for the study has ceased. Initially posted on October 2nd 2017 and last edited on May 3rd 2022, it is now inactive. If you are searching other trials relating to prostate cancer there are 1252 studies that remain active while only two TOOKAD Soluble 4 mg/kg clinical trials have open recruiting opportunities."

Answered by AI

Has TOOKAD Soluble 4 mg/kg been the subject of any other research investigations?

"Currently, there are 2 active clinical trials testing the efficacy of TOOKAD Soluble 4 mg/kg; one is in its final stretch with Phase 3. The bulk of these studies are occurring within New york City limits, though 5 different medical centres around America are conducting experiments using this compound."

Answered by AI

What maladies has TOOKAD Soluble 4 mg/kg been demonstrated to alleviate?

"TOOKAD Soluble 4 mg/kg is a viable solution for those suffering from untampered photochemotherapeutic malignant neoplasms of the prostate."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
How old are they?
18 - 65
What site did they apply to?
Memorial Sloan-Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.
2017. "Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03315754.
~7 spots leftby Apr 2025
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