Phase II Laser Focal Therapy of Prostate Cancer

Launched by HALO DIAGNOSTICS · Sep 15, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for prostate cancer called MR-guided laser focal therapy. The goal of the research is to see how safe and effective this treatment is, and to check if it helps control cancer over a long period—up to 20 years. The treatment uses a special laser system that targets and heats cancer cells in the prostate to destroy them. This is the first time this particular laser system has been tested for prostate cancer, and it will be guided by advanced imaging technology that creates detailed pictures of the prostate.

To participate in this trial, candidates must be men aged 45 or older who have been diagnosed with early-stage prostate cancer. They should also have a specific cancer score and meet other health criteria, such as being able to tolerate anesthesia and having a good chance of living for at least five more years. Participants will undergo a procedure where doctors will guide the laser to the cancerous area using MRI imaging. It’s important to note that not everyone will qualify, especially those with certain medical conditions, such as severe urinary issues or a recent history of other cancers. If you're interested and think you might qualify, talking to your doctor can be a great next step.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• Treatment Naïve patients:
• • Male, 45 years of age or older.
• • Diagnosis of prostate adenocarcinoma.
• • Clinical stage T1c or T2a.
• • Gleason score of 7 (3+4 or 4+3) or less.
• • Three or fewer biopsy cores with prostate cancer.
• • PSA density not exceeding 0.375.
• • One, two, or three tumor suspicious regions identified on multiparametric MRI.
• • Negative radiographic indication of extra-capsular extent.
• • Karnofsky performance status of at least 70.
• • Estimated survival of 5 years or greater, as determined by treating physician.
• • Tolerance for anesthesia/sedation.
• • Ability to give informed consent.
• • At least 6 weeks since any previous prostate biopsy.
• • MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.
• • Salvage candidates will be accepted upon physician referral.
• Exclusion Criteria:
• • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• • Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
• • History of other primary non-skin malignancy within previous three years.
• • Diabetes
• • Smoker