Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
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
Sponsor: SpectraCure AB
A observational or N/A phase clinical study on Recurrent Prostate Cancer, this trial is actively recruiting participants. The trial is conducted by SpectraCure AB and has accumulated 16 data snapshots since 2017. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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 IDOSE® Software) and verteporfin for injection (VFI) is a safe treatment for recurrent prostate cancer.
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 IDOSE® Software) and verteporfin for injection (VFI) is a safe treatment for recurrent prostate cancer.
Status Flow
Change History
16 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
-
Sep 2025 — May 2026 [monthly]
Recruiting PHASE1/PHASE2
-
Jan 2025 — Sep 2025 [monthly]
Recruiting PHASE1/PHASE2
-
Sep 2024 — Jan 2025 [monthly]
Recruiting PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
▶ Show 11 earlier versions
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May 2023 — Jul 2024 [monthly]
Recruiting PHASE1_PHASE2
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Mar 2023 — May 2023 [monthly]
Recruiting PHASE1_PHASE2
-
Dec 2022 — Mar 2023 [monthly]
Recruiting PHASE1_PHASE2
Phase: PHASE1 → PHASE1_PHASE2
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Sep 2022 — Dec 2022 [monthly]
Recruiting PHASE1
Status: Unknown Status → Recruiting
-
Oct 2021 — Sep 2022 [monthly]
Unknown Status PHASE1
Status: Recruiting → Unknown Status
-
Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE1
-
Feb 2020 — Jan 2021 [monthly]
Recruiting PHASE1
-
Jun 2019 — Feb 2020 [monthly]
Recruiting PHASE1
-
Oct 2018 — Jun 2019 [monthly]
Recruiting PHASE1
-
Jun 2018 — Oct 2018 [monthly]
Recruiting PHASE1
-
May 2017 — Jun 2018 [monthly]
Recruiting PHASE1
First recorded
Mar 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- SpectraCure AB
For direct contact, visit the study record on ClinicalTrials.gov .