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Tests treatment safety and results for Recurrent Prostate Cancer
Official title Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
ClinicalTrials.gov ID: NCT03067051
What this study is testing
What is Verteporfin?
Verteporfin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent prostate cancer.
Also referred to as Visudyne.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Phase 1
- Males \> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with...
- Prostate volume less than 50 cm3 defined by transrectal ultrasound
- Subject not eligible for surgery or curative radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
- Patients who have been treated with seed implantation brachytherapy
- Gleason score ≥ 8 at initial diagnosis
- Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
- Concomitant infection
- people with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
See the full eligibility criteria
- Phase 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.
- Prostate volume less than 50 cm3 defined by transrectal ultrasound
- Subject not eligible for surgery or curative radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival ≥ 8 months
- Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3
- Adequate renal function as defined by creatinine ≤ 1.5 mg /dl
- 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
- Signed Informed Consent Phase 1
- Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease
- Patients who have been treated with seed implantation brachytherapy
- Gleason score ≥ 8 at initial diagnosis
- Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)
- Concomitant infection
- people with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study
- 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
- Contraindication for photosensitizer
- Porphyria or other diseases exacerbated by light
- Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients
- Known allergies to porphyrins
- Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site
- On-going therapy with a photosensitizing agent
- Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- people 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...
- people \> 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.
- Treatment target volume less than 50 cm3.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 12 months.
- Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
- Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
- 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...
- Signed Informed Consent. Phase 2 Exclusion Criteria:
- people with locally advanced (AJCC 7th edition T3/T4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.
- people who have been treated with seed implantation brachytherapy.
- Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
- Concomitant infection.
- people with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
- 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.
- Contraindication for photosensitizer.
- Porphyria or other diseases exacerbated by light.
- Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.
- Known allergies to porphyrins.
- Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.
- On-going therapy with a photosensitizing agent.
- Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.
- people 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.
- Contraindication for MRI/Gadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate [GFR] \<30 mL/min/1.73m2, or previous contrast reactions.
- On-going or planned hormone therapy.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Toronto, Ontario, Canada
- Malmö, Skåne County, Sweden
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Toronto, Ontario, Canada; Malmö, Skåne County, Sweden; London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.