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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Vascular targeted photodynamic therapy using TOOKAD Soluble
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
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
Time frame: 12 months
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;
Time frame: 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;
Time frame: 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;
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Up to 60 months
Adverse Events
Collection Adverse events
Time frame: Up to 60 months
PSA
Serum PSA measurements in ng/mL.
Time frame: Months 1, 3, 6, 12, 24, 36, 48, 60