Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: Focal Therapy for Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06491056

CIRB 2023/2055

Details and patient eligibility

About

This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia

Full description

Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.

Enrollment: 500 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate Adenocarcinoma
• Maximum Gleason score 4+4
• Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
• Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
• Maximum clinical stage T2c
• American Society of Anesthesiologist Criteria 2 or less

Exclusion criteria

• Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted

Trial design

500 participants in 1 patient group

Focal Therapy for Prostate Cancer

Description:

Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of \<75% of the prostate gland.

Treatment:

Device: Focal Therapy for Prostate Cancer