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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03067051
Other study ID # SPC11-01-110
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 21, 2017
Est. completion date December 31, 2024

Study information

Verified date April 2023
Source SpectraCure AB
Contact Johannes Swartling
Phone +46 (0) 46 16 20 70
Email jsw@spectracure.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.


Description:

In 2011, more than 200,000 men in North America alone were diagnosed with cancer of the prostate, which makes it one of the most common cancer types. It affects the lives of the subjects in many ways. After treatment the subjects PSA levels are being closely monitored to detect potential recurrence. A high number of subjects will get recurrent prostate cancer. The treatment options for recurrent cancer are more limited than for primary tumors as secondary treatment partly depends on which treatment the subject has previously undergone. Treatment of recurrent prostate cancer may, depending on the standard treatment of the primary disease, include the following: - Radiation therapy. - Prostatectomy for subjects initially treated with radiation therapy. - Hormone therapy. - Pain medication, external radiation therapy, internal radiation therapy with radioisotopes such as strontium-89, or other treatments as palliative therapy to lessen bone pain. The objectives of this study is to demonstrate that the use of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSEĀ® Software) and verteporfin for injection (VFI) is a safe treatment for recurrent prostate cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Verteporfin
In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).
Device:
SpectraCure P18 System
Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system

Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario
Sweden Skåne University Hospital Malmö Skåne
United Kingdom Reader in Urology, University College London & Honorary Consultant Urological Surgeon, University College London Hospitals Trust London
United States Memorial Sloan Kettering Cancer Center New York New York
United States Keith Cengel Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
SpectraCure AB

Countries where clinical trial is conducted

United States,  Canada,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment related adverse events as assesses by CTCAE v4.0 related to protocol therapy. Dose limiting toxicities are defined as grade 3 non-hematologic or grade 4 hematologic toxicities that are possibly, probably or definitely related to PDT. Within 4 weeks of treatment in each cohort.
Primary Percentage of subjects with negative biopsies. Histopathologically tumor-free. 6 months following PDT.
Secondary Damage to the periprostatic tissues including the rectal wall mediated by PDT Potential damage to the periprostatic tissue will be evaluated by contrast-enhanced and not-contrast enhanced MRI. 5-9 days following PDT
Secondary Performance of SpectraCure P18 system Performance of the SpectraCure P18 system will be evaluated by light dose-volume histograms for the light dose coverage Dose-volume histograms will be evaluated at month 12
Secondary Adequacy of effectiveness Effectivity will be evaluated by MRI to determine the extent of necrosis in the prostate Within 1 week of treatment
Secondary Percentage of subjects with remaining localized tumour. Evaluated by MRI. 12 months following PDT.
Secondary Percentage of subjects with biochemical failure. Failure defined as a rise in PSA level of 2.0 ng/mL or more, over and above the nadir. 12 months following PDT.
Secondary Percentage of subjects with extra prostatic or distant disease. Evaluated by PSMA PET. 12 months following PDT.
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