Authorised Phase I and Phase II (Integrated)- First administration to humans Recurrent prostate cancer

Study to assess the safety and efficacy of the SpectraCure P18 System

EU CTIS ID: 2022-502285-24-00

What this study is testing

(i) demonstrate that the use of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) is a safe treatment for patients with recurrent prostate cancer, and (ii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate, deliver and control the required light dose for elimination of cancer cells in locally recurrent prostate cancer tumours, and (iii) demonstrate that the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) is able to calculate the precise positioning of the fibers for maximum effective light delivery, and (iv) determine the lowest safe and effective drug dose as well as the lowest safe and effective light dose as determined by MRI response and adverse events. (v) ascertain the dose level and assess clinical efficacy of the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software) and verteporfin for injection (VFI) for treatment of recurrent prostate cancer.

Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Phase 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.
Phase 2: 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.
Phase 2: Treatment target volume less than 50 cm3.
Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Phase 2: Expected survival ≥ 12 months.
Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.

You likely can't join if

Phase 1: Patients with locally advanced (AJCC 7th edition T3/T4) or metastatic disease.
Phase 1: Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).
Phase 1: Concomitant infection
Phase 1: Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.
Phase 1: 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.
Phase 1: Contraindication for photosensitizer

See the full eligibility criteria

Who can join

Phase 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.
Phase 2: 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.
Phase 2: Treatment target volume less than 50 cm3.
Phase 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Phase 2: Expected survival ≥ 12 months.
Phase 2: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
Phase 2: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
Phase 2: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
Phase 2: Signed Informed Consent.
Phase 1: Treatment target volume less than 50 cm3 defined by transrectal ultrasound.
Phase 1: Subject not eligible for surgery or curative radiotherapy.
Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Phase 1: Expected survival ≥ 8 months.
Phase 1: Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500/mm3, platelet count ≥ 100,000/mm3.
Phase 1: Adequate renal function as defined by creatinine ≤ 1.5 mg /dl.
Phase 1: Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg/dl, serum glutamateoxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.
Phase 1: Signed Informed Consent

What rules you out

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

The study team makes the final eligibility decision.

Where it's taking place

United States
Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.