Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.

NCT03315754 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: CLIN1601 PCM204
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Negative Biopsy for Gleason Grade 4 or 5 Prostate Cancer on 12-month Post-treatment

  Binary response to treatment defined as absence of Gleason grade 4 or 5 on biopsy on 12-month post-treatment following TOOKAD® Soluble VTP in men with Gleason score 7 (3+4) prostate cancer

  12 months

Secondary Outcomes (13)

• Absence of Gleason Grade 4 or 5

  months 24, 36, 48 and 60

• Absence of Any Prostate Cancer on Biopsy

  months 3, 12, 24, 36 and 60

• Absence of Any Gleason 4 or 5 in the Treated Lobe

  months 12, 24, 36, 48 and 60

• Absence of Any Prostate Cancer on Biopsy in the Treated Lobe

  months 3, 12, 24, 36, 48 and 60

• Changes in Biopsy Parameters (Gleason Score)

  months 3, 12, 24, 36, 48 and 60

Study Arms (1)

TOOKAD Soluble 4 mg/kg

EXPERIMENTAL

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.

Drug: TOOKAD Soluble 4 mg/kg

Interventions

TOOKAD Soluble 4 mg/kg DRUG

Vascular targeted photodynamic therapy using TOOKAD Soluble

Also known as: WST11

TOOKAD Soluble 4 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men over 18 years of age.
• Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any volumes considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
• Histologic diagnosis of prostate cancer identifying Gleason score of 3+4 on one half of the prostate gland in no more than 2 sextants of the prostate gland and not present in more than 50% of any one core taken systematically. The involvement criterion does not apply to cores taken from MRI suspicious volumes.
• Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any core at any site will be considered eligible.
• Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
• Prostate volume ≥25 mL and ≤70 mL.
• Serum PSA ≤10 ng/mL.
• Men who are sexually active with women of childbearing potential must use contraceptive method with a failure rate of less than 1% per year. Contraception should be continued for a period of 90 days after the VTP procedure. The individual methods of contraception may be determined in consultation
• Signed Informed Consent Form.

You may not qualify if:

• Unwillingness to accept the treatment;
• Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy;
• Any surgical intervention for benign prostatic hypertrophy;
• Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
• Life expectancy less than 10 years;
• Participation in another clinical study involving an investigational product within 1 month before study entry;
• Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks, especially inability to understand and fulfill the health-related QOL questionnaire;
• Subjects in custody and or residing in a nursing home or rehabilitation facility;
• Biopsy proven locally advanced or metastatic prostate cancer.
• Any condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., cardiac or respiratory disease precluding general anesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure).
• Medical conditions that preclude the use of general anesthesia;
• Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;
• Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production within the previous 6 months;
• History of urethral stricture disease;
• History of acute urinary retention within 6 months of study entry;

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

padeliporfin

Results Point of Contact

• Title: Jonathan Coleman, MD
• Organization: Memorial Sloan Kettering Cancer Center, New York, NY, USA

colemanj@mskcc.org

+1-646-422-4432

Study Officials

• Jonathan Coleman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 20, 2017
• Study Start: October 2, 2017
• Primary Completion: November 2, 2020
• Study Completion: February 2, 2025
• Last Updated: December 20, 2024
• Results First Posted: August 2, 2023

Record last verified: 2024-10

Locations

US (1)