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

Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Localized Intermediate Risk Prostate Cancer.

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Localized Prostate Cancer
• Intervention / Treatment: Drug: TOOKAD Soluble 4 mg/kg

Detailed Description

This is a single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial. The primary objective of the study is 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. Men with Gleason score 7 (3+4) prostate cancer on one half of the prostate will receive TOOKAD® Soluble VTP under general anesthesia. Treatment will consist in hemiablation procedure designed to destroy the lobe of the prostate gland that contains the Gleason score 7 (3+4) cancer. Afterwards, patients will be followed for 5 years (60 months) with clinical evaluation, questionnaires on QOL, erectile and urinary functions, and PSA testing. In addition, treatment outcomes will be assessed based on prostate biopsy results at 3, 12, 24, 36, 48 and 60 months after the TOOKAD® Soluble treatment. All patients will undergo biopsy at 3 and 12 months. If the Month 3 biopsy is positive for any cancer, patients will be allowed a single re-treatment by TOOKAD® Soluble VTP to one or both lobes.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men over 18 years of age.
2. 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.
3. 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.
4. Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any core at any site will be considered eligible.
5. Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
6. Prostate volume ≥25 mL and ≤70 mL.
7. Serum PSA ≤10 ng/mL.
8. 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
9. Signed Informed Consent Form.

Exclusion Criteria:

1. Unwillingness to accept the treatment;
2. Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy;
3. Any surgical intervention for benign prostatic hypertrophy;
4. Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
5. Life expectancy less than 10 years;
6. Participation in another clinical study involving an investigational product within 1 month before study entry;
7. 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;
8. Subjects in custody and or residing in a nursing home or rehabilitation facility;
9. Biopsy proven locally advanced or metastatic prostate cancer.
10. 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).
11. Medical conditions that preclude the use of general anesthesia;
12. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;
13. Hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production within the previous 6 months;
14. History of urethral stricture disease;
15. History of acute urinary retention within 6 months of study entry;
16. Condition requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone) if these treatments could not be stopped at least 10 days before and for 3 days after the VTP procedure or replaced by treatments without photosensitizing properties;
17. Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the VTP procedure and 3 days after VTP;
18. Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment);
19. A history of sun hypersensitivity or photosensitive dermatitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TOOKAD Soluble 4 mg/kg; 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; Vascular targeted photodynamic therapy using TOOKAD Soluble; Other Names: WST11

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA	Serum PSA measurements in ng/mL.	Months 1, 3, 6, 12, 24, 36, 48, 60
Absence of Gleason Grade 4 or 5	Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 24, 36, 48 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;	months 24, 36, 48 and 60
Absence of Any Prostate Cancer on Biopsy	Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36 and 60. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded;	months 3, 12, 24, 36 and 60
Absence of Any Gleason 4 or 5 in the Treated Lobe	Binary response to treatment defined as the absence of any Gleason grade 4 or 5 biopsy on or before months 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of gleason grade 4 or 5, the subject will be considered to have responded;	months 12, 24, 36, 48 and 60
Absence of Any Prostate Cancer on Biopsy in the Treated Lobe	Binary response to treatment defined as the absence of any prostate cancer on biopsy on or before months 3, 12, 24, 36, 48 and 60 in the treated lobe. If a subject is retreated following a positive biopsy at 3 months and subsequent biopsy shows absence of any cancer, the subject will be considered to have responded	months 3, 12, 24, 36, 48 and 60
Changes in Biopsy Parameters (Gleason Score)	Changes in biopsy parameters (Gleason score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies	months 3, 12, 24, 36, 48 and 60
Changes in Biopsy Parameters (Number of Positive Score)	Changes in biopsy parameters (number of positive score) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies	months 3, 12, 24, 36, 48 and 60
Changes in Biopsy Parameters (Cancer Core Length)	Changes in biopsy parameters (cancer core length) between the baseline biopsy and Month 3, Month12, Month 24, Month 36, Month48 and Month 60 biopsies	months 3, 12, 24, 36, 48 and 60
IPSS Questionnaire	Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS (changes in IPSS scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)	months 1, 3, 6, 12, 24, 36, 48 and 60
IIEF15 Questionnaire	Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF 15 (changes in IIEF 15 scores from baseline to 1, 3, 6, 12, 24, 36, 48 and 60 months after treatment)	months 1, 3, 6, 12, 24, 36, 48 and 60
Severe Prostate Cancer-related Events	Severe prostate cancer-related events: cancer extension to T3, metastasis or prostate cancer-related death	Up to 60 months
Secondary Prostate Cancer Treatment	Use of secondary prostate cancer treatment following VTP will include surgical removal of the prostate gland, radiation treatment to the prostate gland, use of hormone or chemotherapies	Up to 60 months
Adverse Events	Collection Adverse events	Up to 60 months

Collaborators and Investigators

• Sponsor: Steba Biotech S.A.
• Investigators: Principal Investigator: Jonathan Coleman, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): November 2, 2020
• Study Completion (Estimated): November 2, 2024

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CLIN1601 PCM204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No