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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called TOOKAD Soluble for men with localized prostate cancer. The goal is to determine if this treatment can eliminate high-risk cancer cells in the prostate. Participants will receive the treatment under general anesthesia and will be monitored for cancer cells a year later. Men who might be suitable for this trial include those diagnosed with prostate cancer with a Gleason score of 7 (3+4) and who have not yet undergone any prostate cancer treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires stopping certain medications, like those with photosensitizing effects and anticoagulants, at least 10 days before and for 3 days after the procedure. If you are on these medications, you may need to switch to alternatives without these effects.

Is there any evidence suggesting that TOOKAD Soluble is likely to be safe for humans?

Studies have shown that TOOKAD Soluble is generally well-tolerated by patients with localized prostate cancer. Research indicates that many patients did not experience significant side effects after receiving this treatment. For example, one study found that 49% of patients showed no clear signs of cancer in their tissues after 24 months, compared to only 14% who did not receive the treatment. This suggests that TOOKAD Soluble is effective and safe for most people.

Another study reported that TOOKAD Soluble caused only minor side effects, indicating its relative safety. Most patients did not report major issues after the treatment. This is encouraging for those considering joining a trial, as it indicates a low risk of serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for prostate cancer that often involve surgery or radiation therapy, TOOKAD Soluble offers a novel approach by using a combination of a light-sensitive drug and laser light. This treatment involves a one-time 10-minute IV infusion of TOOKAD Soluble, followed by a focused laser light activation. The unique mechanism, called vascular-targeted photodynamic therapy (VTP), specifically targets the blood vessels feeding the cancer, potentially reducing side effects and preserving healthy tissue. Researchers are excited because this method offers a targeted, minimally invasive option that could lead to quicker recovery and fewer complications compared to standard treatments.

What evidence suggests that TOOKAD Soluble might be an effective treatment for prostate cancer?

Research has shown that TOOKAD Soluble may effectively treat localized prostate cancer. In one study, 94% of patients responded positively to the treatment, with tumors no longer detectable in half of these cases. Another study found that TOOKAD Soluble worked well for patients with intermediate-risk prostate cancer and had few side effects. Long-term follow-up confirmed its effectiveness and showed minimal impact on urinary and sexual function. Overall, these findings suggest that TOOKAD Soluble could be a strong option for reducing or eliminating prostate cancer tumors. Participants in this trial will receive TOOKAD Soluble at a dose of 4 mg/kg, followed by laser light treatment, to evaluate its effectiveness further. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Coleman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10265489/

Final Results of a Phase I Trial of WST-11 (TOOKAD ... In evaluating efficacy, VTP demonstrated tumor response in the majority (94%) of patients, with CR seen in half of patients after one treatment. Complete ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01310894

NCT01310894 | Efficacy and Safety Study of TOOKAD® ... A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for localised prostate cancer compared to active surveillance.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.e17006

Phase 2b trial results of padeliporfin (WST11 or Tookad) ... The positive results from this trial show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer, with minimal toxicity or impact on urinary ...

4. impactbiotech.com impactbiotech.com/impact-biotech-presents-updated-efficacy-data-from-evaluation-of-padeliporfin-vtp-in-lg-utuc-and-intermediaterisk-prostate-cancer-at-aua-2025/

Phase 3 trial evaluating Padeliporfin VTP in UTUC Padeliporfin demonstrated minimal long-term toxicity including low impact on urinary and sexual function, consisted with the safety and ...

5. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109960.86805.2e.06

PD19-06 48 MONTH FOLLOW UP OF RESULTS OF THE ... These positive trial results show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer with minimal long-term toxicity.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24028764/

TOOKAD(®) Soluble vascular-targeted photodynamic (VTP ... Overall, the treatment was well tolerated and exhibited early signs of efficacy for minimally invasive focal treatment of localised prostate cancer. Keywords: ...

7. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/tookad

Tookad | European Medicines Agency (EMA) After 24 months, 49% of patients treated with Tookad had no definitive signs of cancer in their tissues compared with 14% of patients who received no treatment.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01875393

Efficacy,Safety and Quality of Life After TOOKAD® Soluble ... The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients. Detailed ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11852660/

The Safety and Efficacy of Vascular-Targeted Photodynamic ... The aim of this paper is to evaluate the safety and efficacy of vascular-targeted photodynamic therapy in low-risk PCa.