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FDA didn't approve the design of the protocol so we didn't start the study
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Multi-center, prospective, randomized controlled clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer. The study will include criteria for evaluation, biopsy, eligibility, informed consent, subsequent management and decision making conducted based on data provided locally at each center that follow a set of standardized criteria.
The primary endpoint requires follow-up through 30 months, but all subjects will be followed for 72 months regardless of initiation of other local or systemic prostate cancer treatments, which will allow assessments of recurrence rates and morbidity after conversion to radical therapy, long-term safety and tolerability, as well as oncologic outcomes.
This is multi-center, prospective, randomized controlled phase III clinical trial that will compare two treatment methods (PGA with TOOKAD® VTP and Active Surveillance) for treating localized prostate cancer who meet the inclusion criteria will be approached for participation in the clinical study. Patients consenting to participate will be individually randomized to TOOKAD® VTP or Active Surveillance with a 1:1 ratio. Central randomization will be performed using an independent web-based allocation system. Randomization will be stratified by center using minimization. Ongoing assessment of patients in both arms will be balanced, including follow up examinations, PSA testing, MRI and biopsies at defined intervals.
Subjects in the experimental arm will receive the experimental treatment consisting of unilateral TOOKAD® VTP treatment applied to the index lobe containing pattern 4 cancer. The treatment will be administered under general anesthesia. Routine ultrasound examination in the operating room will be performed for morphometric description of the prostate and to facilitate accurate treatment planning and probe placement. Ultrasound will not be used for diagnostic purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOOKAD® | Experimental | TOOKAD® , lyophilized formulation, given at a dose of 4mg/Kg. |
|
| Active Surveillance | No Intervention | Active surveillance is one of the management strategy in men who have intermediate risk localised prostate cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOOKAD® | Drug | TOOKAD® -VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of objective progression | To evaluate the difference in the rate of objective progression of cancer between men treated with TOOKAD -VTP and men managed with Active Surveillance for localized prostate cancer. | over 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion to radical local or systemic therapy | To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy | over 30 and 72 months |
| Rate of conversion to radical local or systemic therapy following objective progression |
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Inclusion Criteria:
Exclusion Criteria:
Grade Group 3, 4 or 5 (≥ Gleason Score 4+3=7) cancer
In patients with Grade Group 2 cancers, a total length of Gleason pattern 4 more than 2mm when measured in all systematic biopsy cores plus up to 1 core from each targeted biopsy lesion (if more than 1 core is taken from a given lesion, include the mm of pattern 4 in the 1 core with the longest length of pattern 4)
Bilateral GG 2 cancer
MRI evidence of extracapsular extension of cancer (MRI read as "definite", "frank" or "gross" ECE, or MRI lesion with >10mm capsular contact, in an area with biopsy proven cancer).
Seminal vesicle invasion on DRE or MRI ("probable" or "consistent with")
Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy) or chemotherapy;
Life expectancy less than 10 years;
Participation in another clinical study involving an investigational product that in the opinion of the investigator may interfere with the endpoints or investigational criteria of this study;
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;
Any history of a definitively ablative procedure for benign prostatic disease, such as benign prostatic hyperplasia, including TURP, whether electrosurgical or thermal laser ablation; or high intensity frequency ultrasound (HIFU) or cryotherapy, for focal or total ablative therapy of the prostate.
Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure such as:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Coleman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D011471 | Prostatic Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C456120 | palladium-bacteriopheophorbide |
| C503696 | padeliporfin |
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To confirm the differences between men treated with VTP and men managed with Active Surveillance in overall rate of conversion to radical local or systemic therapy following objective progression |
| over 30 and 72 months |
| Rate of biopsy progression in the index lobe | To confirm the differences between men treated with VTP and men managed with Active Surveillance in the rate of biopsy progression in the index lobe (the lobe initially diagnosed with GG2 cancer) defined as:
| at 30 and 72 months |
| Rate of clinical local or distant progression | The rate of clinical local or distant progression defined as any of the following:
| Screening,Month 12, Month 24,Month 42 and Month 60 |
| Adverse events and Serious Adverse events | The rate, severity, onset and duration of adverse events (AEs) and serious adverse events (SAEs) | Screening-Month 72 |
| FACT-P - Question GP5 - Bother Related to Adverse Events | The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. Only Question GP5 will be assessed to determine bother related to adverse events. | Screening,Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, and Month 36 |
| Urinary:PRO-CTCAE - Urinary Questions 61 - 65 | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Urinary Questions 61 - 65 will be assessed | Screening,Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, and Month 36 |
| Pain: PRO-CTCAE Pain Question 48 | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Pain Question 48 will be assessed | Screening,Week 2, Week 4, Week 6, Week 8, Month 3, Month 4, Month 5, Month 6, Month 12, Month 18, Month 24, and Month 36 |
| Bowel Symptoms: PRO-CTCAE questions 17 and 18 | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Bowel Symptoms questions 17 and 18 will be assessed | Screening,Week 4, Week 8, Month 3, Month 6, Month 12, Month 18, Month 24, and Month 36, Month 48, Month 60, and Month 72 |
| Sexual Function: PRO-CTCAE questions 66-68 and 70-72 | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective. Only Sexual Function questions 66-68 and 70-72 will be assessed | Screening,Week 4, Week 8, Month 3, Month 6, Month 12, Month 18, Month 24, and Month 36, Month 48, Month 60, and Month 72 |
| Anxiety = PRO-CTCAE question 54 | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. These include symptomatic toxicities such as pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient perspective.Only Anxiety question 54 will be assessed | Screening,Week 4, Week 8, Month 3, Month 6, Month 12, Month 18, Month 24, and Month 36, Month 48, Month 60, and Month 72 |
| Anxiety = MAX-PC Questions 15-18 - Anxiety related to fear of prostate cancer recurrence | The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) has been developped to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence. Only Anxiety Questions 15-18 will be assessed | Screening,Month 6, Month 12, Month 18, Month 24, and Month 36, Month 48, Month 60, and Month 72 |
| Assessment feasibility of performing radical, local or systemic treatment | The physician will evaluate the ease or difficulties of radical, local or systemic therapy after VTP procedure using a scale . The instrument to be used to assess feasibility of performing RT will be a 5-point Likert Scale. The question may be similar to the following: "What was the difficulty in performing radical treatment on the subject" and proposed anwers will be: None, Minimal, Moderate, Severe or Extreme | within 90 days after treatment |
| Safety of radical, local or systemic treatment | Safety recorded as incidence of Adverse events and Serious Adverse Events | within 90 days after treatment |
| Biochemical outcomes of radical, local or systemic treatment | Biochemical Response recorded as serum PSA change as absolute measurement in ng/dL and as percentage increase or decrease over time | 6 weeks and 24 months after treatment |
| Clinical recurrence | Clinical recurrence recorded as physician recorded objective recurrence of tumor on physical exam or imaging. | 6 weeks and 24 months after treatment |
| Primary cause for conversion to radical treatment | Identification of the primary cause for conversion to radical treatment as assessed by physician:
| Over 30 and 72 months |
| Assessment of PSA Level | Assessment of PSA level in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA serum level to be recorded as ng/ml | Screening, Day of VTP ,Month 6, Month 18, Month 30, Month 36, Month 48 and Month 72 |
| Assessment of PSA density | Assessment of PSA density in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA density is calculated as total PSA (ng/ml) divided by prostate volume (ml). | Screening, Day of VTP ,Month 6, Month 18, Month 30, Month 36, Month 48 and Month 72 |
| Assessment of PSA kinetics | Assessment of PSA kinetics in predicting or monitoring oncologic outcomes of local recurrence, and local or systemic progression. PSA kinetics is evaluated as change in PSA serum level in ng/ml over time. | Screening, Day of VTP ,Month 6, Month 18, Month 30, Month 36, Month 48 and Month 72 |
| Assessment of MRI dynamic characteristics (change in size of initial lesions) | Change in size of initial lesion on MRI in cm3 | Screening, Month 12,Month 24, Month 42 and Month 60 |
| Assessment of MRI dynamic characteristics (change in PIRADS v2 score of initial lesions) | Change in PIRADS v2 Score of initial lesion | Screening, Month 12,Month 24, Month 42 and Month 60 |
| Assessment of MRI dynamic characteristics (Development of new lesions) | Incidence of new lesions discovered | Month 12,Month 24, Month 42 and Month 60 |
| Assessment of MRI dynamic characteristics (Changes in level of suspicion for ECE, SVI, LN metastases) | Changes in imaging results to indicate potential progression of prostate cancer outside the prostate gland (Changes in level of suspicion for Extra Capsular Extension (ECE), Semical vesicle invasion (SVI), Lymph node (LN) metastases used to identify local recurrence, and local, regional or distant progression). | Screening, Month 12,Month 24, Month 42 and Month 60 |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |