Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

NCT03067051 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: SPC11-01-110
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.

  Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT.

  Within 4 weeks of treatment in each cohort.

• Percentage of subjects with negative biopsies.

  Histopathologically tumor-free.

  6 months following PDT.

Secondary Outcomes (6)

• Damage to the periprostatic tissues including the rectal wall mediated by PDT

  5-9 days following PDT

• Performance of SpectraCure P18 system

  Dose-volume histograms will be evaluated at month 12

• Adequacy of effectiveness

  Within 1 week of treatment

• Percentage of subjects with remaining localized tumour.

  12 months following PDT.

• Percentage of subjects with biochemical failure.

  12 months following PDT.

Study Arms (1)

PDT and verteporfin dose finding

EXPERIMENTAL

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 .

Drug: Verteporfin; Device: SpectraCure P18 System

Interventions

Verteporfin DRUG

In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).

Also known as: Visudyne

PDT and verteporfin dose finding

SpectraCure P18 System DEVICE

Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

PDT and verteporfin dose finding

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with recurrent prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
• Patients who have been treated with seed implantation brachytherapy
• Gleason score ≥ 8 at initial diagnosis
• Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
• Concomitant infection
• Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
• Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator
• Contraindication for photosensitizer
• Porphyria or other diseases exacerbated by light
• Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
• Known allergies to porphyrins
• Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
• On-going therapy with a photosensitizing agent
• Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
• Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.

Sponsors & Collaborators

• SpectraCure AB: lead

Study Sites (4)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, ON M5G 2M9, Canada

RECRUITING

Skåne University Hospital

Malmö, Skåne County, Sweden

RECRUITING

Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust

London, W1W 7TS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Johannes Swartling

CONTACT

+46 (0) 46 16 20 70; jsw@spectracure.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: As result of the accelerated titration design with light dose and verteporfin for injection (VFI), the final number of subjects depends on the outcome of the titration. If all dose levels enroll and complete at the minimum number of subjects, the number of subjects is 12 (1 each at dose levels 1-3, 3 each at dose levels 4-6). If all dose levels enroll and complete at the maximum number of subjects, the number of subjects is 36 (6 subjects at each dose level 1-6). The range is thus 12-36 subjects for the dose-escalation phase. 25-30 subjects will be treated in an expanded cohort.

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 1, 2017
• Study Start: March 21, 2017
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

SE (1); US (1); CA (1); GB (1)