Using light therapy to treat localized prostate cancer

Open-label Clinical Phase 1/2 Study to Assess the Safety and Efficacy of the SpectraCure P18 System and Verteporfin for Injection for the Treatment of Primary Localized Prostate Cancer

This study is testing a new light therapy treatment for localized prostate cancer to see if it is safe and effective for patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: SpectraCure AB (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (New York, New York and 2 other locations)
• Trial ID: NCT06807359 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of the SpectraCure P18 System combined with verteporfin for treating primary localized prostate cancer. It consists of two phases: Phase I focuses on dose escalation to determine safety and effective light dosage, while Phase II expands the cohort to assess clinical efficacy and confirm safety over a follow-up period of 36 months. The treatment involves interstitial photodynamic therapy performed under general anesthesia, utilizing optical fibers to deliver light directly to the prostate. Participants will be monitored for treatment outcomes and tolerability.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 18 and older with histologically confirmed organ-confined prostate cancer and specific Gleason scores and PSA levels.

Not a fit: Patients with advanced prostate cancer or those with a Gleason score outside the specified range may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with localized prostate cancer, potentially improving outcomes and reducing side effects compared to traditional therapies.

How similar studies have performed: While photodynamic therapy has been explored in various contexts, this specific approach using the SpectraCure P18 System is novel and has not been widely tested in similar trials.

Eligibility criteria

Inclusion Criteria:

1. Subjects ≥ 18 years.
2. 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.

   a. This prostate biopsy should be targeted and systematic (transperineal or transrectal are both acceptable) and include both systematic sampling with a minimum of 8 cores (4 right, 4 left) as well as MRI fusion targeted cores. The minimum number of targeted cores is two (2) but more may be included at the discretion of the surgeon.
3. Gleason Score 7 (3+4 or 4+3).
4. PSA ≤ 15 ng/mL.
5. Lesion volume on mpMRI \< 1.5 cm3.
6. Adequate stage imaging such as pelvic CT/MRI/PET scan within the last 6 months confirming localized cancer.

   \- Bone scan is optional if PSA \< 10 ng/mL.
7. Treatment target volume \<50 cm3 defined by TRUS or MRI.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Expected survival ≥ 36 months.
10. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
11. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
12. 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.
13. Signed Informed Consent.

Exclusion Criteria:

1. Evidence of locally advanced, regional pelvic lymph node metastasis, or metastatic disease.
2. Any suspicious for, probable, or definite extracapsular extension on pretreatment MRI
3. Contralateral PIRADS 4/5 lesion (even if negative targeted biopsy)
4. High volume GG1 disease in the contralateral prostate, outside of the ablation zone. High volume is defined as \>1 core of GG1 with a linear amount of carcinoma \>6mm.
5. Prior radical surgery for carcinoma of the prostate, prior pelvic radiation, prior TURP, prior cryosurgery of the prostate.
6. Prior treatment with any form of brachytherapy.
7. Previous androgen deprivation therapy (ADT) or chemotherapy for prostate cancer.
8. Prior or current bleeding diathesis.
9. Tumors known to be eroding into a major blood vessel in or adjacent to the illumination site.
10. Use of Alpha-reductase inhibitors (ARIs) within 90 days of enrolment.
11. 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 (according to investigator's decision).
12. 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.
13. Contraindication for photosensitizer including:

    1. Porphyria or other diseases exacerbated by light.
    2. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
    3. Known allergies to porphyrins.
14. On-going therapy with a photosensitizing agent.
15. Enrolment in another therapeutic clinical study within 3 month prior to enrolment and throughout the study.
16. Contraindication for MRI/Gadolinium contrast such as: implants, hip prosthesis, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2), or previous contrast reactions.
17. Has known hypersensitivity to pancuronium bromide, atricurium or cisatricurium

Where this trial is running

New York, New York and 2 other locations

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Klinik für Urologie, Universitätsklinikum Köln — Cologne, Germany (Recruiting)
• Klinik und Poliklinik für Urologie, Universitätsmedizin Rostock — Rostock, Germany (Recruiting)

Study contacts

• Principal investigator: Jonathan Fainberg, MD, MPH — Memorial Sloan Kettering Cancer Center, New York, United States
• Study coordinator: Kristina Holst

Conditions Prostate Cancer