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

Trial Summary

What is the purpose of this trial?

The goal of this study is to obtain safety data, establish dose parameters, and effectiveness of treatment for the SpectraCure P18 System with IDOSE®, together with verteporfin for injection (VFI) as photosensitizer, for the treatment of primary localized prostate cancer. The study will be divided into two parts, with Phase I, dose-escalation, to study safety and establish an effective light dose, followed by Phase II, cohort expansion, to evaluate clinical efficacy and confirm safety/tolerability. The subjects will be followed for a period of 18 months to determine the primary outcome. The long-term follow-up is an additional 18 months, i.e. a total of 36 months. Interstitial Photodynamic Therapy (PDT) will be performed during general anesthesia. Optical fibers will be inserted into the prostate with a transperineal approach using transrectal ultrasound guidance. The intent is to deliver an adequate light dose throughout the prostate. Subjects will receive VFI intravenously, approximately 60-90 minutes prior to light delivery.

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.

How is Photodynamic Therapy (PDT) different from other treatments for prostate cancer?

Photodynamic Therapy (PDT) is unique because it uses light-sensitive drugs and a specific type of light to kill cancer cells, unlike traditional treatments like androgen deprivation therapy (ADT) which focus on reducing male hormones that fuel cancer growth. PDT is less invasive and targets cancer cells directly, potentially reducing side effects compared to systemic treatments. ^{1 2 3 4 5}

Research Team

Jonathan Fainberg, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center, New York, United States

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy increases brain ageing. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Contemporary role of androgen deprivation therapy for prostate cancer. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The role of androgen deprivation therapy plus radiation therapy in patients with non-metastatic prostate cancer. [2017]