Localized Prostate CancerPhase 2NCT03315754
Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer.
A Phase 2 study testing TOOKAD Soluble 4 mg/kg in people with Localized Prostate Cancer, run by Steba Biotech S.A. at 1 site in United States.
Trial summary
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… 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 Soluble 4 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 over 18 years of age.
- 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.
- 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.
- Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any core at any site will be considered eligible.
- Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
- Prostate volume ≥25 mL and ≤70 mL.
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- Serum PSA ≤10 ng/mL.
- 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
- Signed Informed Consent Form.
Who cannot join
- Unwillingness to accept the treatment;
- Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy;
- Any surgical intervention for benign prostatic hypertrophy;
- Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
- Life expectancy less than 10 years;
- Participation in another clinical study involving an investigational product within 1 month before study entry;
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- 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;
- Subjects in custody and or residing in a nursing home or rehabilitation facility;
- Biopsy proven locally advanced or metastatic prostate cancer.
- 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).
- 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;
- History of urethral stricture disease;
- History of acute urinary retention within 6 months of study entry;
- 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;
- 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;
- 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.
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: 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).
Read the 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.
- Conditions
- Localized Prostate Cancer
- Being tested
- TOOKAD Soluble 4 mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOOKAD Soluble 4 mg/kgDrug
Also called WST11
Vascular targeted photodynamic therapy using TOOKAD Soluble
| Study group | Role | What they receive |
|---|---|---|
| TOOKAD Soluble 4 mg/kg | Experimental | 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. Receives: Drug: TOOKAD Soluble 4 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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
Measured: months 3, 12, 24, 36, 48 and 60
Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe
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;
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Months 1, 3, 6, 12, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start2 Oct 2017
- Primary completion2 Nov 2020
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT03315754
- Sponsor's protocol ID
- CLIN1601 PCM204
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2017
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03315754
- Acronym / sponsor ID
- CLIN1601 PCM204
- Conditions
- Localized Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, single-arm, open-label, 60-month follow-up phase IIb clinical trial
| Arm | Type | Receives |
|---|---|---|
| TOOKAD Soluble 4 mg/kg | Experimental | Drug: TOOKAD Soluble 4 mg/kgTOOKAD® 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men over 18 years of age.
- 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.
- 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.
- Patients with concomitant Gleason score 3+3 prostate cancer in less than 50% of any core at any site will be considered eligible.
- Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
Key exclusion criteria (19 listed)
- Unwillingness to accept the treatment;
- Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy;
- Any surgical intervention for benign prostatic hypertrophy;
- Any condition or history of illness or surgery that might pose an additional risk to men undergoing the VTP procedure;
- Life expectancy less than 10 years;
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 Soluble 4 mg/kgAlso: WST11Vascular targeted photodynamic therapy using TOOKAD Soluble | Drug | TOOKAD Soluble 4 mg/kg |
Primary outcome
Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment
Time frame: 12 months
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
10 secondary outcomes
Absence of Gleason Score 7 ( Gleason Grade 4 or 5) in Entire Prostate
Time frame: 3, 12, 24,36,48, 60 months
Absence of Any Prostate Cancer on Biopsy
Time frame: months 3, 12, 24, 36, 48 and 60
Absence of Gleason Score 7 (Gleason Grade 4 or 5) in the Treated Lobe
Time frame: months 3,12, 24, 36, 48 and 60
Absence of Any Prostate Cancer on Biopsy in the Treated Lobe
Time frame: months 3, 12, 24, 36, 48 and 60
Changes in Biopsy Parameters (Gleason Score)
Time frame: 3,12,24,36,48, 60 months
The International Prostate Symptom Score (IPSS) Questionnaire
Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60
International Index of Erectile Function (IIEF15) Questionnaire
Time frame: months 1, 3, 6, 12, 24, 36, 48 and 60
Severe Prostate Cancer Related Events
Time frame: up to 60 months
Secondary Prostate Cancer Treatment
Time frame: Up to 60 months
PSA
Time frame: Months 1, 3, 6, 12, 24, 36, 48, 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2 study testing TOOKAD Soluble 4 mg/kg 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 9 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: finished, as of the sponsor's last update on 10 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Negative Biopsy for Gleason Score 7 (Gleason Grade 4 or 5) Prostate Cancer on 12-month Post-treatment (time frame: 12 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 10 Sep 2026.