Localized Prostate CancerPhase 3NCT04225299
Evaluation of Efficacy of TOOKAD® (VTP) Versus Active Surveillance for Intermediate Risk Localized Prostate Cancer
A Phase 3 study testing TOOKAD® in people with Localized Prostate Cancer, run by Steba Biotech S.A. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Cancer
- What is being tested?
- TOOKAD®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2020to 1 Jul 2030
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men 18 years or older.
- Men who have chosen Active Surveillance as the treatment for their prostate cancer.
- Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any lesions (or "areas") considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
- Unilateral Grade Group 2 (Gleason grade 3+4=7) prostate cancer with a total length of Gleason pattern 4 no 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 the core with the longest length of pattern 4 will be included). Note: the presence and length of Grade Group 1 (Gleason score 3+3=6) cancer in the biopsy will not be considered when determining eligibility.
- Prostate cancer clinical stage up to cT2a, N0/Nx, M0/Mx.
- Prostate volume ≥20 mL and ≤80 mL
Show all 10Show fewer
- Serum PSA ≤10 ng/mL.
- Patients with cT2a and PSA between 10 and 20 ng/mL will have appropriate imaging and work up to sufficiently exclude clinical evidence of bone metastases (e.g., bone scan, whole body MRI, PET scan, or equivalent). Patients with sites considered "suspicious" may be evaluated with confirmatory biopsy to determine eligibility. Patients with sites considered "definite" or "consistent with" bone metastases will be excluded.
- 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 with the investigator.
- Signed Informed Consent Form.
Who cannot join
- 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.
Show all 19Show fewer
- 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:
- 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;
- Oral anticoagulant drugs that could not be withdrawn at least 5 days prior to the VTP procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn at least 5 days prior to the VTP procedure and for at least 3 days after VTP;
- Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment);
- A history of sun hypersensitivity or photosensitive dermatitis.
- Any other 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 patient (e.g., cardiac or respiratory disease precluding general anesthesia, active urethral stricture disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: An Evaluation of the Efficacy of Partial Gland Ablation (PGA) With TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) Versus Active Surveillance for Men With Intermediate Risk Localized Prostate Cancer
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.
Read the detailed description
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.
- Conditions
- Localized Prostate Cancer
- Being tested
- TOOKAD®
- Keywords
- Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma
- Medical subject headings
- Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Male Urogenital Diseases, Neoplasms, Neoplasms by Site, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOOKAD®Drug
Also called WST11
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
| Study group | Role | What they receive |
|---|---|---|
| TOOKAD® | Experimental | TOOKAD® , lyophilized formulation, given at a dose of 4mg/Kg. Receives: Drug: TOOKAD® |
| Active Surveillance | No intervention | Active surveillance is one of the management strategy in men who have intermediate risk localised prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 30 months
Secondary outcomes (24)
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
Measured: over 30 and 72 months
Rate of conversion to radical local or systemic therapy following objective progression
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
Measured: 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:
- Any Grade Group 3 or higher cancer in a biopsy core of the index lobe
- Increase in total length of Gleason pattern 4 >1mm above baseline and >2mm in total length in a follow-up biopsy of the index lobe
Measured: 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:
- Clinical stage ≥ T3N0M0 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, identified as "probable" or "definite," on DRE or MRI
- Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
- Metastatic disease
- Prostate cancer-specific death
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: within 90 days after treatment
Safety of radical, local or systemic treatment
Safety recorded as incidence of Adverse events and Serious Adverse Events
Measured: 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
Measured: 6 weeks and 24 months after treatment
Clinical recurrence
Clinical recurrence recorded as physician recorded objective recurrence of tumor on physical exam or imaging.
Measured: 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:
- Pre-defined cancer progression
- Changes in clinical parameters in absence of objective progression (physicial examination findings, PSA, imaging (MRI, CT, PET), biopsy, or other tests to be documented such as genomic tests)
- Significant change in anxiety about prostate cancer (Defined as increase of last MAX-PC (Memorial Anxiety Scale for Prostate Cancer)-fear of recurrence score prior to conversion to radical therapy by 3 points or more vs. baseline) in the absence of objective progression or change in clinical parameters
- Patient preference in absence of objective progression, change in clinical parameters, or documented prostate cancer anxiety
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Screening, Month 12,Month 24, Month 42 and Month 60
Assessment of MRI dynamic characteristics (Development of new lesions)
Incidence of new lesions discovered
Measured: 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).
Measured: Screening, Month 12,Month 24, Month 42 and Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Mar 2020 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Why it stopped: FDA didn't approve the design of the protocol so we didn't start the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Coleman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225299
- Sponsor's protocol ID
- CLIN1901 PCM306
- Status last verified
- Oct 2020
- First submitted
- 26 Dec 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy of Partial Gland Ablation (PGA) With TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) Versus Active Surveillance for Men With Intermediate Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT04225299
- Acronym / sponsor ID
- CLIN1901 PCM306
- Conditions
- Localized Prostate Cancer
- Keywords
- Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA didn't approve the design of the protocol so we didn't start the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- 31 Mar 2020 (estimated)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOOKAD® | Experimental | Drug: TOOKAD®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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men 18 years or older.
- Men who have chosen Active Surveillance as the treatment for their prostate cancer.
- Patients who have had a multiparametric MRI of the prostate performed and have undergone transrectal systematic biopsy plus biopsy of any lesions (or "areas") considered suspicious per the MRI (PIRADS version 2 score of 4 or 5) within 6 months before signing consent.
- Unilateral Grade Group 2 (Gleason grade 3+4=7) prostate cancer with a total length of Gleason pattern 4 no 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 the core with the longest length of pattern 4 will be included). Note: the presence and length of Grade Group 1 (Gleason score 3+3=6) cancer in the biopsy will not be considered when determining eligibility.
- Prostate cancer clinical stage up to cT2a, N0/Nx, M0/Mx.
Key exclusion criteria (19 listed)
- 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")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOOKAD®Also: WST11TOOKAD® -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 | Drug | TOOKAD® |
Primary outcome
Rate of objective progression
Time frame: over 30 months
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.
24 secondary outcomes
Rate of conversion to radical local or systemic therapy
Time frame: over 30 and 72 months
Rate of conversion to radical local or systemic therapy following objective progression
Time frame: over 30 and 72 months
Rate of biopsy progression in the index lobe
Time frame: at 30 and 72 months
Rate of clinical local or distant progression
Time frame: Screening,Month 12, Month 24,Month 42 and Month 60
Adverse events and Serious Adverse events
Time frame: Screening-Month 72
FACT-P - Question GP5 - Bother Related to Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within 90 days after treatment
Safety of radical, local or systemic treatment
Time frame: within 90 days after treatment
Biochemical outcomes of radical, local or systemic treatment
Time frame: 6 weeks and 24 months after treatment
Clinical recurrence
Time frame: 6 weeks and 24 months after treatment
Primary cause for conversion to radical treatment
Time frame: Over 30 and 72 months
Assessment of PSA Level
Time frame: Screening, Day of VTP ,Month 6, Month 18, Month 30, Month 36, Month 48 and Month 72
Assessment of PSA density
Time frame: Screening, Day of VTP ,Month 6, Month 18, Month 30, Month 36, Month 48 and Month 72
Assessment of PSA kinetics
Time frame: 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)
Time frame: Screening, Month 12,Month 24, Month 42 and Month 60
Assessment of MRI dynamic characteristics (change in PIRADS v2 score of initial lesions)
Time frame: Screening, Month 12,Month 24, Month 42 and Month 60
Assessment of MRI dynamic characteristics (Development of new lesions)
Time frame: Month 12,Month 24, Month 42 and Month 60
Assessment of MRI dynamic characteristics (Changes in level of suspicion for ECE, SVI, LN metastases)
Time frame: Screening, Month 12,Month 24, Month 42 and Month 60
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Coleman, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOOKAD® in people with Localized Prostate Cancer, run by Steba Biotech S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of objective progression (time frame: over 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.