Photodynamic Therapy for Prostate Cancer

Overseen By Kristina Holst

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: SpectraCure AB

Must not be taking: Alpha-reductase inhibitors, Photosensitizing agents

Disqualifiers: Metastatic disease, Prior prostate surgery, others

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

Compensation: Varies

Number of Visits: Unknown

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat localized prostate cancer using photodynamic therapy (PDT). The researchers aim to determine the safety and effectiveness of this treatment when combined with the drug verteporfin (an injection). PDT uses light to activate the drug, which may help fight cancer cells in the prostate. The trial seeks men diagnosed with prostate cancer within the last nine months who have not received certain prior treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot use Alpha-reductase inhibitors within 90 days of joining. Also, you can't be on any ongoing therapy with a photosensitizing agent.

What prior data suggests that the SpectraCure P18 System with IDOSE® and verteporfin for injection is safe for treating prostate cancer?

Research has shown that photodynamic therapy (PDT) with verteporfin is generally well-tolerated by patients. Studies have found that verteporfin, which targets blood vessels, is safe. These studies also indicate that PDT is effective, practical, and can be repeated for treating conditions like prostate cancer.

Although PDT remains in the early stages of clinical development, it has been compared to more invasive treatments like radical prostatectomy, which involves surgically removing the prostate. PDT has demonstrated fewer risks and causes less trauma, allowing patients to experience fewer side effects and recover more quickly.

It is important to remember that this trial is in its early stages, so researchers are still collecting safety data. However, the ongoing clinical testing of PDT for prostate cancer offers some reassurance about its safety. As always, joining a clinical trial may involve unknown risks, so discussing these with a healthcare provider is crucial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Most treatments for prostate cancer, like surgery, radiation, or hormone therapy, focus on removing or shrinking tumors. However, Photodynamic Therapy (PDT) with Verteporfin for Injection (VFI) offers a unique approach. This treatment uses a special drug activated by light to directly target cancer cells, minimizing damage to surrounding healthy tissue. Researchers are excited because PDT could potentially result in fewer side effects and a quicker recovery compared to more invasive treatments. Additionally, its targeted nature might lead to more precise elimination of cancerous cells.

What evidence suggests that this Photodynamic Therapy is effective for prostate cancer?

Research has shown that photodynamic therapy (PDT) with verteporfin, which participants in this trial will receive, holds promise for treating prostate cancer. In one study with 12 men, 95% of the treatments succeeded, and 83% of these men showed no signs of cancer in their biopsy after six months. Another study found that 74% of participants experienced positive results 12 months after treatment. These findings suggest that PDT with verteporfin could be a strong option for treating localized prostate cancer. This treatment uses light and a special drug to target and kill cancer cells while minimizing harm to nearby healthy tissue. ^{1 2 4 6 7}

Who Is on the Research Team?

Jonathan Fainberg, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center, New York, United States

Are You a Good Fit for This Trial?

This trial is for men with primary localized prostate cancer. Participants should be suitable for general anesthesia and the procedure, which involves inserting optical fibers into the prostate. Specific details on who can't join are not provided here.

Inclusion Criteria

Histologically confirmed organ-confined adenocarcinoma of the prostate cancer diagnosed within the last 9 months, including subjects on active surveillance with evidence of disease progression and a prostate biopsy not older than 9 months. The biopsy should be targeted and systematic, including both systematic sampling with a minimum of 8 cores (4 right, 4 left) and MRI fusion targeted cores. Gleason Score 7 (3+4 or 4+3). PSA ≤ 15 ng/mL. Lesion volume on mpMRI < 1.5 cm3. Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer. Treatment target volume <50 cm3 defined by TRUS or MRI. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Expected survival ≥ 36 months. Sufficient bone marrow reserve. Adequate renal function. Adequate hepatic function. Signed Informed Consent.

Exclusion Criteria

Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol

Contraindication for photosensitizer

Known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Dose-escalation

Study safety and establish an effective light dose using the SpectraCure P18 System and Verteporfin for Injection

4 weeks

Multiple visits for dose-escalation and monitoring

Phase II: Cohort expansion

Evaluate clinical efficacy and confirm safety/tolerability of the treatment

18 months

Regular visits for efficacy evaluation and safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Periodic visits for long-term follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Photodynamic Therapy (PDT)
• Verteporfin Injection

Trial Overview The study tests a new treatment called SpectraCure P18 System with IDOSE® and verteporfin injection (VFI) as a photosensitizer in two phases: Phase I to find a safe light dose, and Phase II to test effectiveness and confirm safety over an 18-month period followed by long-term follow-up.

How Is the Trial Designed?

Group I: PDT with VFI Experimental Treatment 2 Interventions

Interstitial Photodynamic Therapy (PDT) and Verteporfin for Injection (VFI)

Who Is Running the Clinical Trial?

SpectraCure AB

Lead Sponsor

Trials

2

Recruited

110+

Published Research Related to This Trial

Androgen deprivation therapy (ADT) remains a crucial treatment for locally advanced and high-risk prostate cancer, especially when combined with radiation therapy (RT), as it has been shown to improve overall survival in these patients.

While ADT with RT offers significant benefits, careful consideration of treatment duration and potential side effects is essential, with emerging evidence suggesting that shorter treatment durations may be effective for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of androgen deprivation therapy plus radiation therapy in patients with non-metastatic prostate cancer. Zhao, S., Urdaneta, AI., Anscher, MS.[2017]

In a study of 50 prostate cancer patients undergoing androgen deprivation therapy (ADT) and 15 control patients, significant cognitive impairment was observed in most ADT patients, indicating potential cognitive risks associated with this treatment.

While there were no significant differences in grey matter volume (GMV) and white matter lesion (WML) load between the ADT and control groups, a negative relationship was found between the duration of ADT and GMV, suggesting that longer ADT exposure may accelerate age-related brain changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy increases brain ageing. Plata-Bello, J., Plata-Bello, A., Pérez-Martín, Y., et al.[2020]

Androgen deprivation therapy (ADT) is effective for prostate cancer, particularly in advanced or metastatic cases, improving quality of life and potentially prolonging survival, but it is not recommended as a primary treatment for nonmetastatic disease due to lack of benefit.

ADT can lead to serious adverse effects, such as cardiovascular disease and diabetes, highlighting the importance of carefully weighing the risks and benefits before implementation, especially in earlier stages of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary role of androgen deprivation therapy for prostate cancer. Pagliarulo, V., Bracarda, S., Eisenberger, MA., et al.[2022]

In a pooled analysis of 920 prostate cancer patients, triptorelin sustained-release formulations effectively suppressed serum testosterone levels to below 20 ng/dl in 79% to 93% of patients over various treatment durations (1 to 12 months).

The study suggests that achieving very low testosterone levels may provide additional clinical benefits, highlighting the importance of routine testosterone monitoring in patients undergoing androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer. Breul, J., Lundström, E., Purcea, D., et al.[2018]

Androgen depletion therapy (ADT) should be reconsidered for early-stage prostate cancer, as recent increases in diagnoses due to PSA screening highlight its potential benefits in localized cases.

Combination therapy using castration and non-steroidal anti-androgens has shown significant effectiveness in treating non-metastatic prostate cancer, suggesting that early intervention with ADT can help prevent progression to more advanced, hormone-independent disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status and prospects of androgen depletion therapy for prostate cancer. Akaza, H.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9538922/

Photodynamic therapy for prostate cancer 95% of treatments were effective of 12 men used these parameters and 83% had negative biopsy at 6 months (51). This therapeutic effect was also validated in a ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-01293

Photodynamic Therapy of Primary Localized Prostate ... The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06807359

Study Details | NCT06807359 | Photodynamic Therapy of ... The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1454392/full

Photodynamic therapy for the precise treatment of localized ... A Latin American trial (PCM304) evaluated the efficacy of PDT in men with prostate cancer. Twelve months after VTP, 60 (74%) patients had ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024004241

Clinical and pre-clinical advances in the PDT/PTT strategy ... This review summarizes recently published clinical trials that used PDT/PTT to diagnostic or treat cancers of breast, prostate, skin, and other tissues.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5444762/

Photosensitizers in prostate cancer therapy - PMC Several clinical trials using vascular targeted photosensitizers have established it as safe, effective, feasible and repeatable. Since the first use of PDT for ...

7. cancerresearchuk.org cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-a-new-way-of-giving-photodynamic-therapy-for-prostate-cancer-spectracure-p18

A trial looking at a new way of giving photodynamic ... This trial is looking at photodynamic therapy to treat prostate cancer that has come back after radiotherapy.