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

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875393
• Other study ID #: CLIN1201 PCM304
• Status: Completed
• Phase: Phase 3
• First received: June 7, 2013
• Last updated: April 17, 2016
• Start date: May 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Steba Biotech S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionPeru: Instituto Nacional de SaludPanama: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• TOOKAD® Soluble
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.

Locations

Country	Name	City	State
Mexico	Hospital General Tlahuac	Mexico DF
Panama	Pan-American Medical Research Institute (PAMRI) then moved to Consultario del Dr Rodriguez	Panama city
Peru	Hospital Nacional Cayetano Heredia	San Martin de Porres

Sponsors (1)

Lead Sponsor	Collaborator
Steba Biotech S.A.

Countries where clinical trial is conducted

Mexico,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Screening, 1, 3, 6 and 12 months after completing treatment	Yes
Secondary	The rate of adverse events.	Adverse event reporting.	Screening-Month 12	Yes
Secondary	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	Month 12	Yes
Secondary	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.	Screening-Month 12	Yes