Prostate CancerPhase 3PCM304NCT01875393
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer
A Phase 3 study testing TOOKAD® Soluble in people with Prostate Cancer, run by Steba Biotech S.A. at 3 sites in 3 countries.
Trial summary
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TOOKAD® Soluble
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2013to Mar 2015
- 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
- Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:
- Gleason 3+3 prostate
- Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
- Clinical stage up to cT2a - N0/Nx - M0/Mx.
- Serum prostate-specific antigen (PSA) ˂ 20ng/ml
- Prostate volume ≥ 25 cc and ≤ 70 cc.
- Male subjects aged 18 years or older.
- Signed Informed Consent Form by the patient.
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 may 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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- Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
- Subject in custody and or in residence in a nursing home or rehabilitation facility.
- Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
- Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
- Any history of urethral stricture disease;
- Any history of acute urinary retention within 6 months of study entry
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Panama1 site
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
Panama City
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 Prostate Cancer
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.
Read the detailed description
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.
Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.
- Conditions
- Prostate Cancer
- Being tested
- TOOKAD® Soluble
- 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 Neoplasms, Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Male Urogenital Diseases, Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOOKAD® SolubleDrug
Also called WST11
The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/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® Soluble | Experimental | TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg. Receives: Drug: TOOKAD® Soluble |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Number of patients with a negative biopsy.
Measured: Month 12
Secondary outcomes (4)
Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires.
Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described
Measured: Screening, 1, 3, 6 and 12 months after completing treatment
The rate of adverse events.
Adverse event reporting.
Measured: Screening-Month 12
The overall cancer burden in the prostate determined by biopsy as compared to baseline.
Total length of cancer present in all cores taken in any given biopsy session
Measured: Month 12
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.
Measured: Screening-Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steba Biotech S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Arturo Rodriguez Rivera, Dr, Principal investigator, Hospital General TlahuacMary Lol Ve Mendoza Medina, Dr, Principal investigator, Hospital General TlahuacLuis Zegarra Montes, Professor, Principal investigator, Hospital Nacional Cayetano HerediaRamón Rodriguez, Professor, Principal investigator, Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875393
- Sponsor's protocol ID
- CLIN1201 PCM304
- Acronym
- PCM304
- Status last verified
- Apr 2016
- First submitted
- 7 Jun 2013
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data are available in case report form for each patient
Publications
Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.
PubMed 25712310
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. 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 Prostate Cancer
- ClinicalTrials.gov ID
- NCT01875393
- Acronym / sponsor ID
- PCM304 / CLIN1201 PCM304
- Conditions
- 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
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Steba Biotech S.A.University, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Jun 2013 (estimated)
- 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.
The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.
Detailed description
The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.
Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOOKAD® Soluble | Experimental | Drug: TOOKAD® SolubleTOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg. |
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)
- Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:
- Clinical stage up to cT2a - N0/Nx - M0/Mx.
- Serum prostate-specific antigen (PSA) ˂ 20ng/ml
- Prostate volume ≥ 25 cc and ≤ 70 cc.
- Male subjects aged 18 years or older.
Key exclusion criteria (12 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 may 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® SolubleAlso: WST11The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance. | Drug | TOOKAD® Soluble |
Primary outcome
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Time frame: Month 12
Number of patients with a negative biopsy.
4 secondary outcomes
Changes in urinary and erectile functions and their potential impact on quality of life using International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF) and the General quality of life (EQ5D) questionnaires.
Time frame: Screening, 1, 3, 6 and 12 months after completing treatment
The rate of adverse events.
Time frame: Screening-Month 12
The overall cancer burden in the prostate determined by biopsy as compared to baseline.
Time frame: Month 12
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Time frame: Screening-Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Derived from this study: PubMed 25712310Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.
- Individual participant dataSharing planned: Yes. The data are available in case report form for each patient
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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.
Jose Arturo Rodriguez Rivera, Dr principal investigator
Hospital General Tlahuac
Mary Lol Ve Mendoza Medina, Dr principal investigator
Hospital General Tlahuac
Luis Zegarra Montes, Professor principal investigator
Hospital Nacional Cayetano Heredia
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOOKAD® Soluble in people with Prostate Cancer, run by Steba Biotech S.A. at 3 sites in 3 countries.
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 12 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico, Panama, Peru. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy. (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875393, which also lists 1 linked publication.
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 19 Apr 2016.