Photodynamic Therapy for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Johannes Swartling

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: SpectraCure AB

Must not be taking: Photosensitizing agents, Hormone therapy

Disqualifiers: Metastatic disease, Severe concurrent disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 week

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for men with recurrent prostate cancer after radiation therapy. It employs photodynamic therapy, which uses a special drug called verteporfin and a laser system (SpectraCure P18 System) to target cancer cells. The trial aims to assess the safety and effectiveness of this approach and determine the optimal dosage. It may suit men whose prostate cancer has returned after radiation and who are not eligible for further surgery or radiation. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on ongoing therapy with a photosensitizing agent or have planned hormone therapy.

What prior data suggests that the SpectraCure P18 System and verteporfin are safe for treating recurrent prostate cancer?

Earlier studies have tested the SpectraCure P18 System with the drug verteporfin for safety in treating prostate cancer. These studies aimed to assess the treatment's safety and determine the correct dose. So far, the treatment appears well-tolerated, with no major safety issues reported.

Verteporfin is already approved for some eye conditions, indicating general safety when used correctly. However, its use with the SpectraCure P18 System for prostate cancer remains under study to ensure safety for this specific application.

Overall, current research indicates that the treatment shows promise in terms of safety, but ongoing studies are crucial to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for prostate cancer because it uses a unique combination of photodynamic therapy (PDT) with a drug called verteporfin. Unlike traditional treatments like surgery or radiation, which directly target the tumor, this approach involves injecting verteporfin, a photosensitizer, and then activating it with laser light delivered through the SpectraCure P18 System. This method specifically targets cancer cells while sparing healthy tissue, potentially reducing side effects. Additionally, this therapy can be precisely controlled and adjusted, offering a tailored approach that could enhance treatment effectiveness and patient outcomes.

What evidence suggests that the SpectraCure P18 System with verteporfin is effective for recurrent prostate cancer?

In this trial, participants will receive treatment using the SpectraCure P18 System combined with verteporfin. Studies have shown that this combination holds promise for treating recurrent prostate cancer. Verteporfin increases cancer cells' sensitivity to light, aiding in their destruction. Research indicates that using the correct light dosage with verteporfin can effectively treat about 80% of the prostate, potentially lowering PSA levels, a marker for tracking prostate cancer. Early findings suggest this combination can successfully target and damage prostate cancer cells. Although further research is necessary, these initial results offer encouragement for those considering this treatment. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My prostate is smaller than 50 cm3 as measured by ultrasound.

My liver tests are within normal limits.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I currently have an infection.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Interventional Photodynamic Therapy of Prostate Cancer combined with verteporfin as a photosensitizer using the SpectraCure P18 System

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI evaluations and PSA level monitoring

12 months

Multiple visits (in-person and virtual) over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SpectraCure P18 System
• Verteporfin

Trial Overview 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.

How Is the Trial Designed?

Group I: PDT and verteporfin dose finding Experimental Treatment 2 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 .

SpectraCure P18 System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as SpectraCure P18 System for:

• Recurrent prostate cancer

Approved in European Union as SpectraCure P18 System for:

• Recurrent prostate cancer

Approved in Canada as SpectraCure P18 System for:

• Recurrent prostate cancer

Who Is Running the Clinical Trial?

SpectraCure AB

Lead Sponsor

Trials

2

Recruited

110+

Published Research Related to This Trial

Photodynamic therapy (PDT) for prostate cancer in canines showed that the optical properties of the prostate vary significantly, with higher attenuation coefficients at the base compared to the midsection and apex, which is crucial for effective treatment planning.

The study established a critical fluence of 1449 mJ/cm2 necessary to induce tissue necrosis, highlighting the importance of measuring and monitoring optical parameters in real-time to optimize treatment and protect surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical characteristics of the canine prostate at 665 nm sensitized with tin etiopurpurin dichloride: need for real-time monitoring of photodynamic therapy. Jankun, J., Lilge, L., Douplik, A., et al.[2012]

In a study involving 7748 patients and 8323 treated eyes across 47 hospitals, verteporfin photodynamic therapy (VPDT) demonstrated safety comparable to randomized trials, with adverse reactions reported in only 1.4% of first visits.

The effectiveness of VPDT in routine clinical practice showed similar deterioration in best-corrected visual acuity (BCVA) over time compared to previous trials, but the treatment was administered less frequently, indicating potential differences in real-world application versus clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Verteporfin photodynamic therapy for neovascular age-related macular degeneration: cohort study for the UK. Reeves, BC., Harding, SP., Langham, J., et al.[2022]

In a study involving 13 male dogs, intra-arterial (i.a.) injection of the photosensitizer SL052 resulted in either complete ablation or significant reduction of prostate tissue, demonstrating a highly effective treatment for prostate cancer compared to intravenous (i.v.) administration.

The i.a. method led to more complete photo-ablation of prostate tissue and had manageable side effects, such as temporary acute urinary retention, with no cases of incontinence reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lipophilic photosensitizer administration via the prostate arteries for photodynamic therapy of the canine prostate. Xiao, Z., Owen, RJ., Liu, W., et al.[2013]

In a study involving 948 patients with age-related macular degeneration, photodynamic therapy using verteporfin showed a safety profile comparable to placebo, with similar rates of ocular and nonocular adverse events.

The most notable adverse effects associated with verteporfin were visual disturbances and acute severe visual acuity decrease, but these did not significantly impact the overall vision benefits of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment Of Age-Related Macular Degeneration With Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4. Azab, M., Benchaboune, M., Blinder, KJ., et al.[2019]

In a study of 301 patients with wet age-related macular degeneration, photodynamic therapy using Verteporfin showed that about two-thirds of patients experienced stabilization of their vision, with a decrease of less than 3 lines on visual acuity charts over an average follow-up of 21 months.

Despite an overall drop in mean best corrected visual acuity from 0.708 to 1.016 logMAR, the treatment was effective in maintaining vision for a significant portion of patients, indicating its potential as a viable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photodynamic therapy with Verteporfin in treatment of wet form ARMD - long term results]. Vysloužilová, D., Kolář, P., Matušková, V., et al.[2018]

Photodynamic therapy (PDT) using the photosensitizer tin etiopurpurin shows promise as a minimally invasive treatment for organ-confined prostate cancer, potentially reducing the morbidity associated with traditional ablative therapies.

A new computer program was developed to improve the accuracy of PDT by accounting for the non-linear light distribution and varying optical properties of the prostate, resulting in a predictive model that closely matches observed treatment outcomes in animal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diverse optical characteristic of the prostate and light delivery system: implications for computer modelling of prostatic photodynamic therapy. Jankun, J., Keck, RW., Skrzypczak-Jankun, E., et al.[2019]

Verteporfin therapy leads to short-lived skin photosensitivity, peaking at 1.5 hours post-treatment and decreasing rapidly, with a duration of 2 to 6.7 days depending on the dose.

In clinical trials, only 2.2% of patients experienced photosensitivity reactions, indicating a low incidence of adverse effects, which could be minimized with proper skin protection following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration of skin photosensitivity and incidence of photosensitivity reactions after administration of verteporfin. Houle, JM., Strong, HA.[2019]

In a study involving 402 patients treated with verteporfin for age-related macular degeneration (AMD), 53% experienced minimal visual acuity loss after 24 months, compared to 38% in the placebo group, indicating significant efficacy of verteporfin in preserving vision.

The benefits of verteporfin therapy were particularly notable in patients with predominantly classic choroidal neovascularization (CNV), where 59% maintained visual acuity, while those with minimally classic lesions showed no significant improvement, suggesting targeted use of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials-tap report 2. Bressler, NM.[2022]

Interstitial photodynamic therapy (PDT) using motexafin lutetium has been shown to be a safe treatment for recurrent prostate adenocarcinoma in both canine and human subjects, with 16 canines and 16 human participants involved in the studies.

Despite its safety, there is significant variability in the dose distribution of PDT, which can lead to inconsistent therapeutic outcomes; future efforts will focus on developing a system to monitor and adjust these doses in real-time for better treatment reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of interstitial motexafin lutetium-mediated PDT for prostate cancer. Du, KL., Mick, R., Busch, TM., et al.[2022]

A new interstitial laser light delivery system using multiple optical fibers was developed for photodynamic therapy (PDT) in prostate cancer, allowing for precise positioning of the fibers within 2 mm using transrectal ultrasonography.

In a study involving seven patients, the system demonstrated effective light penetration into prostate tissue, although there was significant variability in light levels due to factors like blood pooling, indicating a need for further refinement to ensure consistent treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interstitial light assembly for photodynamic therapy in prostatic carcinoma. Lee, LK., Whitehurst, C., Pantelides, ML., et al.[2019]

Citations

1. urotoday.com urotoday.com/clinical-trials/prostate-cancer/115457-open-label-clinical-study-to-assess-the-safety-and-adequacy-of-effectiveness-of-the-spectracure-p18-system-interstitial-multiple-diode-lasers-and-idose-software-and-verteporfin-for-injection-vfi-for-the-treatment-of-recurrent-prostate-cancer.html?tags=14633,14634,16432,14635,14636,14637,1

Open-label Clinical Study to Assess the Safety and Efficacy ... The rationale for the study is to obtain safety data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-spectracure-p18-system-and-verteporfin-for-treating-recurrent-prostate-cancer/

Study on the Safety and Effectiveness of SpectraCure P18 ... This study investigates the safety and efficacy of the SpectraCure P18 System and verteporfin in treating recurrent prostate cancer.

3. trialstoday.org trialstoday.org/trial/NCT03067051

Clinical Study to Assess the Safety and Efficacy of ... 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 ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-02485

Clinical Study to Assess the Safety and Efficacy of ... 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®, ...

5. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/spectracure-p18-study/

SpectraCure P18 Study The purpose of this research study is to establish the safety and effectiveness of the SpectraCure P18 System and Verteporfin for the treatment of recurrent ...

6. ancora.ai ancora.ai/es/details/NCT03067051

Clinical Study to Assess the Safety and Efficacy of ... 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 .