Clinical trial NCT01875393: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostatic Disease
Genital Neoplasm,male
Urogenital neoplasm
Genital disease,male
Male urogenital disease
Neoplasms
Neoplasms by site
Prostatic neoplasm
Carcinoma
Lead sponsor: Steba Biotech S.A.
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To confirm that a significant proportion of patients will be prostate cancer free on the biopsy.
timeFrame: Month 12
Secondary outcomes:
measure: 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.
timeFrame: Screening, 1, 3, 6 and 12 months after completing treatment
measure: The rate of adverse events.
timeFrame: Screening-Month 12
measure: The overall cancer burden in the prostate determined by biopsy as compared to baseline.
timeFrame: Month 12
measure: The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death
timeFrame: Screening-Month 12
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
facility: Hospital General Tlahuac
city: Panama city
country: Panama
facility: Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
city: San Martin de Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia
Study officials:
affiliation: Hospital General Tlahuac
name: Jose Arturo Rodriguez Rivera, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Tlahuac
name: Mary Lol Ve Mendoza Medina, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nacional Cayetano Heredia
name: Luis Zegarra Montes, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez
name: Ramón Rodriguez, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.