What side effects are associated with this type of intervention?

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, chemotherapy, and newer methods like photodynamic therapy (PDT). PDT with Verteporfin, a photosensitizer activated by light, can cause side effects such as photosensitivity reactions, local pain, swelling, and inflammation at the treatment site. Other treatments like surgery and radiation therapy may lead to urinary incontinence, erectile dysfunction, bowel issues, and fatigue. Hormone therapy can result in hot flashes, reduced libido, and bone thinning, while chemotherapy often causes nausea, hair loss, and increased infection risk.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced prostate cancer, including androgen receptor signaling inhibitors like enzalutamide, apalutamide, and darolutamide, which block androgen receptors to inhibit cancer growth. Additionally, radioligand therapies such as lutetium Lu 177 vipivotide tetraxetan have been approved for PSMA-positive metastatic castration-resistant prostate cancer (CRPC). While these treatments do not involve photodynamic mechanisms like verteporfin, they represent significant advancements in targeting and managing advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to Photodynamic Therapy with Verteporfin for prostate cancer patients include: 1) Ra-223 (Radium-223) combined with osteoclast inhibitors, which has shown improved survival and reduced fracture risk in metastatic castration-resistant prostate cancer (CRPC). 2) Docetaxel combined with Ra-223, which has demonstrated durable decreases in serum tumor markers in chemotherapy-naïve CRPC patients. 3) Beta-emitting radioisotopes like Strontium-89 and Samarium-153, which have been evaluated for their efficacy in treating bone metastases. These alternatives offer new avenues for treatment and may provide benefits over traditional photodynamic therapy.

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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

Must not have

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

Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following pdt.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a new treatment using lasers and a special drug for men whose prostate cancer has returned. The laser activates the drug to destroy cancer cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am mentally capable of understanding and consenting to participate in the trial.

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My tumor is growing into a major blood vessel near the treatment area.

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I am currently on or planning to start hormone therapy.

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I have had severe or long-lasting inflammation of the rectum from radiation.

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I have undergone seed implantation brachytherapy.

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I currently have an infection.

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My cancer is advanced or has spread to other parts of my body.

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My initial prostate cancer diagnosis had a high severity score.

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I have a condition that worsens with light exposure.

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I cannot take drugs that increase sensitivity to light.

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I am currently being treated with a drug that increases sensitivity to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following pdt.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Biopsy

Secondary study objectives

Adequacy of effectiveness

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

Percentage of subjects with biochemical failure.

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Photodynamic Therapy (PDT) with Verteporfin involves administering a photosensitizing agent (Verteporfin) that accumulates in cancer cells. When exposed to a specific wavelength of light, Verteporfin is activated and produces reactive oxygen species, leading to cellular destruction and tumor necrosis. This targeted approach minimizes damage to surrounding healthy tissues, which is crucial for prostate cancer patients to reduce side effects and preserve quality of life. Other common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, and chemotherapy, each with different mechanisms such as physically removing the tumor, using radiation to kill cancer cells, or disrupting hormonal signals that fuel cancer growth.