Assessing the safety and effectiveness of the SpectraCure P18 System for recurrent prostate cancer

Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer

This study is testing a new laser treatment for men with recurrent prostate cancer to see if it is safe and effective for those who can't have surgery or other types of radiation.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: SpectraCure AB (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (New York, New York and 3 other locations)
• Trial ID: NCT03067051 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of the SpectraCure P18 System, which utilizes interstitial multiple diode lasers and verteporfin for injection as a photosensitizer, in treating recurrent prostate cancer. The study aims to establish dose parameters and monitor PSA levels post-treatment to detect potential recurrence. Eligible participants include males over 18 years who have experienced local recurrence after prior radiation therapy and are not candidates for surgery or curative radiotherapy. The study is conducted in multiple locations, including prominent cancer centers in New York, Toronto, and Malmö.

Who should consider this trial

Good fit: Ideal candidates are males over 18 years with histopathologically verified local recurrence of prostate cancer after prior radiation therapy.

Not a fit: Patients with locally advanced or metastatic prostate cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, safe option for men with recurrent prostate cancer who have limited treatment alternatives.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using laser therapy for cancer treatment, indicating potential for success.

Eligibility criteria

Phase 1 Inclusion Criteria:

1. Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
2. Prostate volume less than 50 cm3 defined by transrectal ultrasound
3. Subject not eligible for surgery or curative radiotherapy
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Expected survival ≥ 8 months
6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
7. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
8. 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
9. Signed Informed Consent

Phase 1 Exclusion Criteria:

1. Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
2. Patients who have been treated with seed implantation brachytherapy
3. Gleason score ≥ 8 at initial diagnosis
4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
5. Concomitant infection
6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
7. 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
8. Contraindication for photosensitizer
9. Porphyria or other diseases exacerbated by light
10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
11. Known allergies to porphyrins
12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
13. On-going therapy with a photosensitizing agent
14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.

Phase 2 Inclusion Criteria:

1. Subjects \> 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
2. Treatment target volume less than 50 cm3.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Expected survival ≥ 12 months.
5. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
6. Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
7. 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.
8. Signed Informed Consent.

Phase 2 Exclusion Criteria:

1. Subjects with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
2. Subjects who have been treated with seed implantation brachytherapy.
3. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
4. Concomitant infection.
5. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
6. 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.
7. Contraindication for photosensitizer.
8. Porphyria or other diseases exacerbated by light.
9. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
10. Known allergies to porphyrins.
11. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
12. On-going therapy with a photosensitizing agent.
13. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
14. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.
15. Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \[GFR\] \<30 mL/min/1.73m2, or previous contrast reactions.
16. On-going or planned hormone therapy.

Where this trial is running

New York, New York and 3 other locations

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
• Skåne University Hospital — Malmö, Skåne County, Sweden (Recruiting)
• Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Johannes Swartling

Conditions Recurrent Prostate Cancer