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Device

Photodynamic Therapy for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by SpectraCure AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following pdt.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses light to kill cancer cells. They are testing to see if it is safe and what the best dose is.

Who is the study for?
Men over 18 with recurrent prostate cancer after radiation therapy, not eligible for surgery or further curative radiotherapy. They must have a prostate volume under 50 cm3, an ECOG status of 0 or 1, life expectancy over 8 months, and adequate bone marrow, kidney and liver function. Excluded are those with advanced/metastatic disease, recent brachytherapy or surgery, infections, mental incapacity affecting consent/follow-up ability, concurrent clinical study participation within the last three months before this trial's start.Check my eligibility
What is being tested?
The SpectraCure P18 System using IDOSE® technology is being tested alongside verteporfin as a photosensitizer to treat recurrent prostate cancer. The goal is to gather safety data and establish effective dosage parameters for this combination treatment.See study design
What are the potential side effects?
Potential side effects may include reactions related to light sensitivity due to verteporfin such as skin reactions when exposed to sunlight or bright indoor lights. Other possible side effects could be specific organ-related responses due to the nature of photodynamic therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver tests are within normal limits.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate is smaller than 50 cm3 as measured by ultrasound.
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I cannot have surgery or curative radiotherapy for my condition.
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My treatment area is smaller than 50 cubic centimeters.
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I am a man over 18 who had radiation for prostate cancer and now have a confirmed local recurrence.
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My kidney function is good, with creatinine ≤ 1.5 mg/dl.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following pdt.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following pdt. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy.
Biopsy
Secondary outcome measures
Adequacy of effectiveness
Damage to the periprostatic tissues including the rectal wall mediated by PDT
Percentage of subjects with biochemical failure.
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PDT and verteporfin dose findingExperimental Treatment2 Interventions
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 .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verteporfin
FDA approved

Find a Location

Who is running the clinical trial?

SpectraCure ABLead Sponsor

Media Library

SpectraCure P18 System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03067051 — Phase 1 & 2
Prostate Cancer Research Study Groups: PDT and verteporfin dose finding
Prostate Cancer Clinical Trial 2023: SpectraCure P18 System Highlights & Side Effects. Trial Name: NCT03067051 — Phase 1 & 2
SpectraCure P18 System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03067051 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key aims of this medical experiment?

"This clinical trial will last for 6 months and measure adverse events related to the protocol therapy, utilizing CTCAE version 4.0 as a metric. Secondary outcomes include the number of patients with localized tumour (assessed via MRI), extra-prostatic or distant disease (assessed by PSMA PET) and any damage done to periprostate tissues due to PDT which can be evaluated through contrast-enhanced/non-contrast enhanced MRI scanning."

Answered by AI

How many volunteers have been recruited for this experiment?

"Affirmative. According to clinicaltrials.gov, this study is accepting applicants from 3 different medical locations and needs 66 participants in total. The trial was initially posted on March 21st 2017 and its details were last updated November 15th 2022."

Answered by AI

Can you elucidate any precedent for combining photodynamic therapy and verteporfin to determine dosage?

"Currently, 5 studies regarding PDT and verteporfin dose finding are underway. None of these trials have reached the Phase 3 stage yet. Despite being based in Winston-Salem, North carolina, there are 10 different locations that offer this treatment as part of a clinical trial."

Answered by AI

Is this investigation currently enrolling participants?

"Affirmative. Per the clinicaltrials.gov website, this research project is presently recruiting participants. It was first advertised on March 21st 2017 and has been recently updated on November 15th 2022. Sixty-six individuals are being accepted from three separate medical centres."

Answered by AI

In what kind of medical scenarios is photodynamic therapy (PDT) and verteporfin dose finding implemented?

"Photodynamic therapy (PDT) combined with verteporfin dose finding has been demonstrated to be effective in managing pathologic myopia, subfoveal choroidal neovascularization (CNV), and age-related macular degeneration (AMD)."

Answered by AI
~3 spots leftby Jul 2024