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Recruiting INTERVENTIONAL NCT03067051

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

Updated 16 times since 2017 Last updated: Apr 27, 2026 Started: Mar 21, 2017 Primary completion: Jul 31, 2027 Completion: Dec 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~May 2017 – ~Jun 2018 · 13 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jun 2019 · 8 months · monthly snapshot~Jun 2019 – ~Feb 2020 · 8 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jul 2024 · 14 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – ~May 2026 · 8 months · monthly snapshotMay 4, 2026 – present · 4 months · daily API

Change History

16 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE1/PHASE2None

  2. Sep 2025 — May 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Jan 2025 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Jan 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

Show 11 earlier versions
  1. May 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Mar 2023 — May 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Dec 2022 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Phase: PHASE1PHASE1_PHASE2

  4. Sep 2022 — Dec 2022 [monthly]

    Recruiting PHASE1

    Status: Unknown StatusRecruiting

  5. Oct 2021 — Sep 2022 [monthly]

    Unknown Status PHASE1

    Status: RecruitingUnknown Status

  6. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  7. Feb 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  8. Jun 2019 — Feb 2020 [monthly]

    Recruiting PHASE1

  9. Oct 2018 — Jun 2019 [monthly]

    Recruiting PHASE1

  10. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE1

  11. 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

Sponsor contact:
  • SpectraCure AB
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .