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
Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment
This outcome reports the percent of participants with response to treatment defined as absence of high-grade cancer (Gleason score 7 (Gleason grade 4 or 5) on bilateral biopsy at 12-month post VTP treatment. The Gleason grading system is a histopathological scale used to evaluate the aggressiveness of prostate cancer. The Gleason score is determined by summing the two most predominant histological patterns observed in tumor tissue, each graded on a scale from 1 (well-differentiated) to 5 (poorly differentiated). The total Gleason score ranges from 2 to 10, with higher scores indicating more aggressive disease. PP (per protocol) is all participants who met all key eligibility criteria at baseline and did not have any major deviations that could invalidate eligibility or the integrity/timing of the 12-month biopsy (biopsy missing/out of window, or pre-12-month salvage therapy). ITT( intent-to treat) is all patients who undergo VTP procedure, regardless of protocol deviations
Time frame: 12 months
Absence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate
Binary response to treatment defined as the absence of Gleason score 7 ( Gleason grade 4 or 5 ) biopsy at or before months 3, 12, 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: 3, 12, 24,36,48, 60 months
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, 48 and 60
Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe
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Binary response to treatment defined as the absence of Gleason score 7 (Gleason grade 4 or 5) biopsy at 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 Gleason grade 4 or 5, the subject will be considered to have responded;
Time frame: months 3,12, 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
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 (Gleason score 7 (3+4) and months 3, 12, 24, 36, 48 , 60 biopsies. The Gleason grading system is a histopathological scale used to assess prostate cancer aggressiveness, with total scores ranging from 2 to 10 (sum of two predominant patterns graded 1-5). Higher scores indicate more aggressive disease. This outcome reports the proportion of participants with absence of high-grade cancer (no Gleason score \<7 (Gleason pattern \< 4 or 5) in the treated lobe at each time point
Time frame: 3,12,24,36,48, 60 months
The International Prostate Symptom Score (IPSS) Questionnaire
The International Prostate Symptom Score (IPSS) is a 7 item questionnaire assessing lower urinary tract symptom severity. Each item is scored from 0 to 5, item scores are summed to give a total score ranging from 0 to 35. Higher scores indicate more severe symptoms and a worse outcome. Scores of 0-7 indicate mild, 8-19 moderate and 20-35 severe symptoms. Patient-reported outcome measures (PROMs) impairment: urinary symptoms using IPSS prior to treatment beginning and then 1, 3, 6, 12, 24, 36, 48 and 60 months after completing treatment
Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60
International Index of Erectile Function (IIEF15) Questionnaire
The International Index of Erectile Function (IIEF 15) is a 15 item questionnaire assessing male sexual function. Item scores are summed to obtain a total score ranging s from 5 to 75. Higher total scores indicate better sexual function and therefore a better outcome.
Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60
Severe Prostate Cancer Related Events
Severe prostate cancer-related events defined as 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
PSA
Serum PSA measurements in ng/mL at visit 0 (baseline) and at follow up visits at 1, 3, 6,12,24,36,48 and 60 months.
Time frame: Months 1, 3, 6, 12, 24, 36, 48, 60