TOOKAD Soluble for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Steba Biotech S.A.

Must not be taking: Photosensitizing drugs, Anticoagulants

Disqualifiers: Prior prostate cancer treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. Men with localized prostate cancer will receive TOOKAD® Soluble VTP under general anesthesia. To evaluate the absence of biopsy detectable Gleason grade 4 or 5 prostate cancer tumors anywhere in the prostate gland on 12-month, post-treatment biopsy following TOOKAD® Soluble-VTP in men with prostate cancer Gleason score 7(3+4).

Research Team

Jonathan Coleman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My prostate cancer is in an early stage and hasn't spread to lymph nodes or other parts.

Signed Informed Consent Form

Serum PSA ≤10 ng/mL

Exclusion Criteria

Subjects in custody and or residing in a nursing home or rehabilitation facility

A history of sun hypersensitivity or photosensitive dermatitis

I am not willing to undergo the treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TOOKAD® Soluble VTP under general anesthesia for hemiablation of the prostate gland

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with clinical evaluations, questionnaires, and PSA testing

60 months

Regular visits at months 3, 12, 24, 36, 48, and 60

Treatment Details

Interventions

• TOOKAD Soluble

Trial Overview 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.

Participant Groups

Group I: TOOKAD Soluble 4 mg/kg Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Steba Biotech S.A.

Lead Sponsor

Trials

17

Recruited

1,300+