None listed
Conditions
Brief summary
Prostate cancer recurrences have limited treatment options with current whole gland surgery or systemic therapy associated with significant morbidity. Focal therapy with the Profocal laser may offer men with recurrent prostate cancer post-radiotherapy a safe and efficacious treatment option. This study will assess the safety of the laser focal therapy device in 40 men.
Interventions
PROFOCAL Laser focal therapy device will be used to treat prostate cancer lesions within the prostate. Treatment will be delivered by surgeons who have (Therapeutic Goods Administration (TGA) Authorised Prescriber approval to use the device. The treatment is delivered under General Anaesthesia at Nepean Public Hospital in one session typically lasting 90-120 minutes.
Treatment is delivered via a transperineal (percutaneously) approach (with transrectal ultrasound guidance) in a very similar mann
PROFOCAL Laser focal therapy device will be used to treat prostate cancer lesions within the prostate. Treatment will be delivered by surgeons who have (Therapeutic Goods Administration (TGA) Authorised Prescriber approval to use the device. The treatment is delivered under General Anaesthesia at Nepean Public Hospital in one session typically lasting 90-120 minutes. Treatment is delivered via a transperineal (percutaneously) approach (with transrectal ultrasound guidance) in a very similar manner to transperineal prostate biopsy. Post-treatment monitoring includes prostate specific antigen (PSA) blood test at 3 months then 12 months, quality of life questionnaires at 3 and 12 months, and MRI +/- biopsy within the first 12 months.
Sponsors
Medlogical Innovations
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Confirmed diagnosis of prostate adenocarcinoma and for whom prostate tissue ablation is clinically warranted (less than 6 months prior to enrolment) • Radiologically targetable lesion • Biopsy concordant cancer distribution • PSA less than or equal to 20ng/mL (performed less than 3 months prior to enrolment) • Clinical Stage – localised to prostate gland • Failed primary radiation therapy
Exclusion criteria
• Known metastatic disease or use of hormone deprivation therapy • Bleeding disorders • History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (including fistula and stenosis) • Active untreated urinary tract infection • Presence of extra-prostatic spread of the cancer based on CT or PET scan • Other sever, acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risks associated with study participation
Outcome results
None listed