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

NCT01875393 | Completed Phase 3

• 1 other identifier: CLIN1201 PCM304
• Study Type: interventional
• Target: 81
• Locations: 3 countries
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostatic Disease; Genital Neoplasm,male; Urogenital neoplasm; Genital disease,male; Male urogenital disease; Neoplasms; Neoplasms by site; Prostatic neoplasm; Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Number of patients with a negative biopsy.

  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.

  Screening, 1, 3, 6 and 12 months after completing treatment

• The rate of adverse events.

  Screening-Month 12

• The overall cancer burden in the prostate determined by biopsy as compared to baseline.

  Month 12

• The rate of severe prostate cancer related events: cancer extension to T3, metastasis and prostate cancer related death

  Screening-Month 12

Study Arms (1)

TOOKAD® Soluble

EXPERIMENTAL

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

Drug: TOOKAD® Soluble

Interventions

TOOKAD® Soluble DRUG

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.

Also known as: WST11

TOOKAD® Soluble

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Steba Biotech S.A.: lead

Study Sites (3)

Hospital General Tlahuac

Mexico City, 13278, Mexico

Location

Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez

Panama City, Panama

Location

Hospital Nacional Cayetano Heredia

San Martín de Porres, Peru

Location

Related Publications (1)

• 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.

  PMID: 25712310 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Neoplasms; Neoplasms by Site; Carcinoma

Interventions

padeliporfin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jose Arturo Rodriguez Rivera, Dr

  Hospital General Tlahuac

  PRINCIPAL INVESTIGATOR

• Mary Lol Ve Mendoza Medina, Dr

  Hospital General Tlahuac

  PRINCIPAL INVESTIGATOR

• Luis Zegarra Montes, Professor

  Hospital Nacional Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Ramón Rodriguez, Professor

  Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

PA (1); ME (1); PE (1)