Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer

Who is this study for? Adult male patients with Prostate Cancer
What treatments are being studied? Verteporfin
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.

• Prostate volume less than 50 cm3 defined by transrectal ultrasound

• Subject not eligible for surgery or curative radiotherapy

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Expected survival ≥ 8 months

• Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3

• Adequate renal function as defined by creatinine ≤ 1.5 mg /dl

• Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal

• Signed Informed Consent

• Subjects \> 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.

• Treatment target volume less than 50 cm3.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Expected survival ≥ 12 months.

• Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.

• Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.

• Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.

• Signed Informed Consent.

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sweden
Skåne University Hospital
RECRUITING
Malmo
United Kingdom
Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust
RECRUITING
London
Contact Information
Primary
Johannes Swartling
jsw@spectracure.com
+46 (0) 46 16 20 70
Time Frame
Start Date: 2017-03-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 66
Treatments
Experimental: PDT and verteporfin dose finding
Verteporfin and Interstitial Photodynamic Therapy are the interventions in this dose titration study.~The interventions will be light dose (as laser) using the SpectraCure P18 System and drug intervention with verteporfin as a photosensitizer.~The study will be conducted as a dose titration study to determine the light and drug threshold dose using the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI).~The light is delivered to the tumor via optical fibers and each dose arm will receive Interventional Photodynamic Therapy of Prostate Cancer combined with the drug verteporfin as a photosensitizer .
Related Therapeutic Areas
Sponsors
Leads: SpectraCure AB

This content was sourced from clinicaltrials.gov