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Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer (PCM304)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TOOKAD® Soluble
Sponsored by
Steba Biotech S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Hospital General Tlahuac
  • Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
  • Hospital Nacional Cayetano Heredia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOOKAD® Soluble

Arm Description

TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.

Outcomes

Primary Outcome Measures

To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Number of patients with a negative biopsy.

Secondary Outcome Measures

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
The rate of adverse events.
Adverse event reporting.
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
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.

Full Information

First Posted
June 7, 2013
Last Updated
April 17, 2016
Sponsor
Steba Biotech S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01875393
Brief Title
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer
Acronym
PCM304
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steba Biotech S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatic Disease, Genital Neoplasm,male, Urogenital neoplasm, Genital disease,male, Male urogenital disease, Neoplasms, Neoplasms by site, Prostatic neoplasm, Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOOKAD® Soluble
Arm Type
Experimental
Arm Description
TOOKAD® Soluble, lyophilized formulation,given at a dose of 4 mg/kg.
Intervention Type
Drug
Intervention Name(s)
TOOKAD® Soluble
Other Intervention Name(s)
WST11
Intervention Description
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.
Primary Outcome Measure Information:
Title
To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
Description
Number of patients with a negative biopsy.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
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.
Description
Patients' reported outcome measures (PROMs) impairment: urinary symptoms using IPSS and erectile functions using IIEF. Quality of life using EQ5D will also be described
Time Frame
Screening, 1, 3, 6 and 12 months after completing treatment
Title
The rate of adverse events.
Description
Adverse event reporting.
Time Frame
Screening-Month 12
Title
The overall cancer burden in the prostate determined by biopsy as compared to baseline.
Description
Total length of cancer present in all cores taken in any given biopsy session
Time Frame
Month 12
Title
The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
Description
Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death.
Time Frame
Screening-Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Arturo Rodriguez Rivera, Dr
Organizational Affiliation
Hospital General Tlahuac
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Lol Ve Mendoza Medina, Dr
Organizational Affiliation
Hospital General Tlahuac
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Zegarra Montes, Professor
Organizational Affiliation
Hospital Nacional Cayetano Heredia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramón Rodriguez, Professor
Organizational Affiliation
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Tlahuac
City
Mexico DF
ZIP/Postal Code
13278
Country
Mexico
Facility Name
Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
City
Panama city
Country
Panama
Facility Name
Hospital Nacional Cayetano Heredia
City
San Martin de Porres
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data are available in case report form for each patient
Citations:
PubMed Identifier
25712310
Citation
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.
Results Reference
derived

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Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

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