NCT06807359 Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
| NCT ID | NCT06807359 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | SpectraCure AB |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 43 participants in total. It began in 2025-01-06 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jonathan Fainberg, MD, MPH
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center, New York, United States
Frequently Asked Questions
Who can join the NCT06807359 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06807359 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06807359 currently recruiting?
Yes, NCT06807359 is actively recruiting participants. Contact the research team at clinical@spectracure.com for enrollment information.
Where is the NCT06807359 trial being conducted?
This trial is being conducted at New York, United States, Cologne, Germany, Rostock, Germany.
Who is sponsoring the NCT06807359 clinical trial?
NCT06807359 is sponsored by SpectraCure AB. The principal investigator is Jonathan Fainberg, MD, MPH at Memorial Sloan Kettering Cancer Center, New York, United States. The trial plans to enroll 43 participants.
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