Low Risk Prostate CancerPhase 4NCT03849365
Study of Erectile Dysfunction, Urinary Incontinence and Related QoL After TOOKAD® VTP for Low Risk Prostate Cancer
A Phase 4 study testing TOOKAD VTP in people with Low Risk Prostate Cancer, run by Steba Biotech S.A. at 1 site in France.
Trial summary
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Low Risk Prostate Cancer
- What is being tested?
- TOOKAD VTP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2019to 13 Nov 2020
- Phase
- Phase 4
- 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 over 18 years of age with a life expectancy ≥ 10 years
- -.Unilateral adenocarcinoma of the prostate accurately located and confirmed as unilateral using high resolution biopsy strategies based on current best practice, such as multi- parametric MRI based strategies or template-based biopsy procedures.
- Clinical stage T1c or T2a,
- Gleason Score ≤ 6, based on high-resolution biopsy strategies
- 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1 -2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
- PSA ≤ 10 ng/mL
- If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.
- Signed Informed Consent Form
Who cannot join
- GENERAL EXCLUSION CRITERIA :
- Unwillingness to accept the treatment;
- Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
- Participation in another clinical study involving an investigational product within 1 month before study entry;
- 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;
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- Biopsy proven locally advanced or metastatic prostate cancer.
- SURGERY AND OTHER TREATMENT-RELATED CONDITIONS OF EXCLUSION
- 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 or any medical condition that precludes the administration of a general anaesthetic or invasive procedures.
- Hypersensitivity to the active substance or to the excipient (mannitol)
- Current or prior treatment for prostate cancer.
- Patients who have been diagnosed with cholestasis.
- Current exacerbation of rectal inflammatory bowel disease.
- Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD. Medicinal products that prevent or reduce platelet aggregation should not be started for at least 3 days after the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.
Read the detailed description
This is a multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial. Men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the EEA Marketing Authorisation) will receive TOOKAD® VTP under general anesthesia. The primary objective is to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP. Prior to the TOOKAD® VTP, patients will undergo routine ultrasound examination in the operating room for morphometric description of the prostate and to facilitate accurate treatment guidance for the treatment with TOOKAD® VTP. Treatment will then be applied to the prostate gland as a hemi-ablation procedure designed to destroy the lobe of the prostate gland that contains the cancer. Afterwards, patients will be followed for 12 months with clinical evaluation, data collection on erectile and urinary functions at 1, 2, 3 6 and 12 months, using the Expanded Prostate Cancer Index Composite (EPIC), International Index of Erectile Function (IIEF) and International Prostate Score Symptom (IPSS) questionnaires on Quality Of Life (QOL) and Prostate Specific Antigen (PSA) testing at 3, 6 and 12 months.
The clinical follow-up of patients will follow local standard of care processes, based on recommendations in the European Summary of Product Characteristics (SmPC).
This study is a phase IV pragmatic trial using optimal dose of TOOKAD® and optimal light-energy level conditions that were determined during development and approved by the European Commission.
- Conditions
- Low Risk Prostate Cancer
- Being tested
- TOOKAD VTP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOOKAD VTPDrug
TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 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.
| Study group | Role | What they receive |
|---|---|---|
| TOOKAD VTP | Experimental | TOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 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 VTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated time with toxicity (duration)
Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Measured: 12 months
Cumulated time with toxicity (prevalence)
Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.
Measured: 12 months
Cumulated time with toxicity (area under the curve)
Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Measured: 12 months
Secondary outcomes (12)
Time with erectile dysfunction (duration)
Time to onset, duration, time to resolution of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Measured: 12 months
Time with erectile dysfunction (prevalence)
Prevalence at different points in time of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Measured: 12 months
Time with erectile dysfunction (Area under the curve)
Area under the curve with the presence of erectile dysfunction grade 2 or above, as assessed using the EPIC instrument
Measured: 12 months
Time with urinary incontinence (duration)
Time to onset, duration, time to resolution of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument,
Measured: 12 months
Time with urinary incontinence (prevalence)
Prevalence at different points in time of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Measured: 12 months
Time with urinary incontinence (Area under the curve)
Area under the curve with the presence of urinary Incontinence grade 2 or above, as assessed using the EPIC instrument.
Measured: 12 months
Correspondence between results of EPIC and IIEF instruments
Average variation on urinary symptoms (UI) using the EPIC and IPSS instruments, erectile functions (ED) using the EPIC and IIEF instruments, and bowel function using the EPIC instrument, prior to treatment beginning and then at 1, 2, 3, 6 and 12 months after completing treatment: absolute scores and changes as compared to baseline (absolute difference of means and proportion change)
Measured: 12 months
PSA density
Average changes from baseline in PSA density at month 12
Measured: 12 months
Rate of Adverse Events
Rate of adverse events (AE) of TOOKAD® VTP treatment : all AE, important AE identified in Risk Management Plan (RMP) and suspected AE listed in RMP.
Measured: 12 months
Time to resolution of Adverse events
Time to resolution of adverse events for each adverse event reported
Measured: 12 months
Additional prostate cancer treatments
Rate of additional treatment as decided by local practice, such as radical therapy (surgical removal of the prostate gland, radiation treatment to the prostate gland) or other intervention therapy to the ipsilateral and/or contralateral lobe, use of hormone or chemotherapies.
Measured: 12 months
Extension of prostate cancer
Rate of reported extension of prostate cancer based on locally decided investigations (such as clinical examination, biopsy, Magnetic resonance Imaging (MRI), other).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start21 Jan 2019
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Why it stopped: Early end of enrolment with regards to difficulty met to enrol patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Risk 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- International Drug Development Institute, PrimeVigilance Ltd., UK
- Responsible party
- Sponsor
- Investigators
- Abdel-Rahmène AZZOUZI, Professor, Principal investigator, Centre Hospitalier Universitaire (CHU) ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849365
- Sponsor's protocol ID
- CLIN1802 PCM404
- Other IDs
- 2018-003228-35, 2018
- Status last verified
- Mar 2021
- First submitted
- 24 Jan 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Erectile Dysfunction, Urinary Incontinence and Related Quality of Life After TOOKAD® Vascular Targeted Photodynamic Therapy (VTP) for Minimally Invasive Treatment of Unilateral Low Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03849365
- Acronym / sponsor ID
- CLIN1802 PCM404
- Conditions
- Low Risk Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early end of enrolment with regards to difficulty met to enrol patients
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Collaborators
- International Drug Development Institute, PrimeVigilance Ltd., UK
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 21 Feb 2019 (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.
Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial in men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the European Economic Area (EEA) Marketing Authorisation) to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP.
Detailed description
This is a multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial. Men with unilateral prostate cancer meeting eligibility criteria for the drug (as per the EEA Marketing Authorisation) will receive TOOKAD® VTP under general anesthesia. The primary objective is to assess the occurrence and dynamics of the time with toxicities (urinary incontinence Grade 2 and over and/or erectile dysfunction Grade 2 and over) in patients 12 months following TOOKAD® VTP. Prior to the TOOKAD® VTP, patients will undergo routine ultrasound examination in the operating room for morphometric description of the prostate and to facilitate accurate treatment guidance for the treatment with TOOKAD® VTP. Treatment will then be applied to the prostate gland as a hemi-ablation procedure designed to destroy the lobe of the prostate gland that contains the cancer. Afterwards, patients will be followed for 12 months with clinical evaluation, data collection on erectile and urinary functions at 1, 2, 3 6 and 12 months, using the Expanded Prostate Cancer Index Composite (EPIC), International Index of Erectile Function (IIEF) and International Prostate Score Symptom (IPSS) questionnaires on Quality Of Life (QOL) and Prostate Specific Antigen (PSA) testing at 3, 6 and 12 months.
The clinical follow-up of patients will follow local standard of care processes, based on recommendations in the European Summary of Product Characteristics (SmPC).
This study is a phase IV pragmatic trial using optimal dose of TOOKAD® and optimal light-energy level conditions that were determined during development and approved by the European Commission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple center, single-arm, open-label, 12-month follow-up phase IV pragmatic clinical trial.
| Arm | Type | Receives |
|---|---|---|
| TOOKAD VTP | Experimental | Drug: TOOKAD VTPTOOKAD is administered as part of focal VTP under general anaesthetic. TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 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 (8 listed)
- Men over 18 years of age with a life expectancy ≥ 10 years
- -.Unilateral adenocarcinoma of the prostate accurately located and confirmed as unilateral using high resolution biopsy strategies based on current best practice, such as multi- parametric MRI based strategies or template-based biopsy procedures.
- Clinical stage T1c or T2a,
- Gleason Score ≤ 6, based on high-resolution biopsy strategies
- 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1 -2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
Key exclusion criteria (14 listed)
- Unwillingness to accept the treatment;
- Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
- Participation in another clinical study involving an investigational product within 1 month before study entry;
- 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;
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 VTPTOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 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. | Drug | TOOKAD VTP |
Primary outcome
Cumulated time with toxicity (duration)
Time frame: 12 months
Time to onset, average duration and average time to resolution (either Erectile Dysfunction (ED) and/or Urinary Incontinence(UI)) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
Cumulated time with toxicity (prevalence)
Time frame: 12 months
Prevalence at different points in time (either ED and/or UI) during the 12 months following VTP of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument.
Cumulated time with toxicity (area under the curve)
Time frame: 12 months
Area under the curve with the presence of ED with severity grade 2 or over and/or UI of severity grade 2 or over, as assessed using the EPIC instrument
12 secondary outcomes
Time with erectile dysfunction (duration)
Time frame: 12 months
Time with erectile dysfunction (prevalence)
Time frame: 12 months
Time with erectile dysfunction (Area under the curve)
Time frame: 12 months
Time with urinary incontinence (duration)
Time frame: 12 months
Time with urinary incontinence (prevalence)
Time frame: 12 months
Time with urinary incontinence (Area under the curve)
Time frame: 12 months
Correspondence between results of EPIC and IIEF instruments
Time frame: 12 months
PSA density
Time frame: 12 months
Rate of Adverse Events
Time frame: 12 months
Time to resolution of Adverse events
Time frame: 12 months
Additional prostate cancer treatments
Time frame: 12 months
Extension of prostate cancer
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Abdel-Rahmène AZZOUZI, Professor principal investigator
Centre Hospitalier Universitaire (CHU) ANGERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TOOKAD VTP in people with Low Risk Prostate Cancer, run by Steba Biotech S.A. at 1 site in France.
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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Mar 2021. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Early end of enrolment with regards to difficulty met to enrol patients). Results are not available in the source record.
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?
Cumulated time with toxicity (duration) (time frame: 12 months). The study lists 3 primary outcomes in all. 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 23 Mar 2021.