Phase 2 Prostate Cancer Trial, Recruiting NCT06807359 Sponsor: SpectraCure AB Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06807359
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 years or older.
  • People with prostate cancer (specifically a type called adenocarcinoma) that has been confirmed by a tissue sample (biopsy) taken within the last 9 months, where the cancer is contained within the prostate gland.
  • People who are on active surveillance for prostate cancer and have shown signs of the disease progressing, with a biopsy taken within the last 9 months.
  • People whose biopsy was done using a specific method that combines at least 8 tissue samples from across the prostate plus additional targeted samples guided by MRI imaging.
  • People with a cancer grade called Gleason Score 7 (either 3+4 or 4+3).
  • People with a PSA blood test result of 15 or below.
  • People whose cancer lesion measured on a specific type of MRI scan is smaller than 1.5 cm³ in volume.
  • People who have had recent imaging (CT, MRI, or PET scan of the pelvis within the last 6 months) confirming the cancer has not spread beyond the prostate.
  • People where the area to be treated measures less than 50 cm³ as seen on ultrasound or MRI.
  • People who are in good general health and able to carry out normal daily activities with little to no limitation (confirm with trial site).
  • People with a life expectancy of at least 36 months.
  • People with adequate bone marrow, kidney, and liver function, as confirmed by blood tests meeting specific thresholds.
  • People who have read, understood, and signed the informed consent form.

Who may not be able to join:

  • People whose cancer has spread beyond the prostate, into nearby lymph nodes, or to other parts of the body.
  • People whose MRI scan shows any signs that the cancer may be growing through the outer wall of the prostate.
  • People with a significant suspicious lesion on the opposite side of the prostate to the treatment area on MRI, even if a biopsy of that area came back negative.
  • People with a high amount of low-grade cancer (Grade Group 1) on the opposite side of the prostate from the treatment area, outside the planned treatment zone (confirm with trial site for specific definition).
  • People who have previously had surgery to remove the prostate, radiation to the pelvis, a procedure called TURP (removal of prostate tissue), or freezing treatment (cryosurgery) of the prostate.
  • People who have previously had brachytherapy (a type of internal radiation treatment).
  • People who have previously received hormone therapy or chemotherapy for prostate cancer.
  • People with a current or past bleeding disorder.
  • People whose tumour is known to be growing into or very close to a major blood vessel near the treatment site.
  • People who have taken alpha-reductase inhibitor medications (a type of prostate medication) within 90 days before joining the trial.
  • People with serious ongoing health conditions, infections, mental health conditions, or other medical issues that the trial investigators determine would prevent safe participation.
  • People who lack the mental capacity to give informed consent or to attend follow-up visits, as assessed by the trial investigators.
  • People with a condition called porphyria, or other conditions made worse by light exposure.
  • People with a known allergy or sensitivity to the light-activated drug used in this trial (verteporfin) or to porphyrin-type substances.
  • People currently taking another medication that makes the skin or body sensitive to light.
  • People who have taken part in another treatment-based clinical trial within the 3 months before joining, or who are currently enrolled in another therapeutic trial.
  • People who cannot have an MRI scan or receive MRI contrast dye, such as those with certain metal implants, hip replacements, severely reduced kidney function, or a history of reactions to contrast dye.
  • People with a known allergy to certain muscle-relaxant medications used during procedures (pancuronium bromide, atracurium, or cisatracurium).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jonathan Fainberg, MD, MPH, Memorial Sloan Kettering Cancer Center, New York, United States

Phone: +46708233630

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
SpectraCure AB
Registry
ClinicalTrials.gov
Start date
6 January 2025
Est. completion
1 January 2028

Where this trial is recruiting

🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Safety of treatment; Safety - Damage to the periprostatic tissue mediated by PDT; Treatment efficacy

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov