You May Prequalify for a Prostate Cancer Clinical Study

Please take the prescreener to answer questions that will evaluate whether or not you may be eligible to participate in the ENLIGHT study. If you are not searching for yourself, please answer the questions on behalf of the person for whom you are searching. All information you enter will remain private. Read our Patient Privacy Policy for more details.

Key eligibility criteria also are summarized as follows:

Inclusion Criteria*

The investigator must complete a medical history and physical examination to assure that all subjects recruited for participation meet all of the following study enrollment criteria:

• Diagnosis of prostate cancer confirmed by PSA and prostate biopsy
• Male subject, age ≥60 years
• Organ-confined prostate cancer, clinical stage T1a, b, or c, or T2a
• At least one positive biopsy within the previous six months
• PSA ≤10 ng/ml
• Gleason Score ≤6
• Histological grading of 3+3, 3+2, 2+3, 2+4, or 2+2 based upon the baseline TRUS-guided 10 core biopsy results (Note: a subject with a histological grading of primary 4 will not be permitted for study enrollment)
• Prostate volume ≤40 cc
• Normal rectal anatomy and rectal mucosa
• Maximum rectal wall measurement 6 mm
• Subject is willing and able to read, understand, and sign the informed consent form
• Subject agrees to comply with study protocol requirements, including study treatment and all follow-up visit requirements through 24 months following treatment and annual study visits until device clearance or the study is terminated by the sponsor

Exclusion Criteria*

Potential subjects recruited for participation must not be enrolled if any of the following conditions exist:

• Evidence of seminal vesicle involvement
• Evidence of lymph node involvement or metastasis
• Any previous treatment for prostate cancer, including radiation therapy, hormone therapy, and/or previous bilateral orchiectomy
• Previous surgery or procedure of the prostate (except prostate biopsy) or urethra within the prior year
• Calcification inducing a shadow in the prostate which cannot be included in the targeted volume
• Large median lobe of the prostate which cannot be included in the target volume
• Use of finasteride or other agents (e.g., saw palmetto) that affect PSA levels within the previous two months
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
• Active inflammatory bowel syndrome
• Current superficial bladder cancer, urethral stricture, or bladder neck contracture
• Active urinary tract infection or prostatitis (the subject may be enrolled once the infection has been treated and has resolved)
• Compromised renal function or upper urinary tract disease as a result of urinary obstruction
• A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
• Urinary tract or rectal fistula
• Anatomical anomaly of the rectum or anomaly of the rectal mucous membrane
• Prostate seroma, prostate abscess, or urethral stenosis
• An intraprostatic implant such as a stent or catheter, or any implant or prosthesis at less than 1 cm from the prostate
• Interest in future fertility
• Concurrent illness, disability, or geographical residence that would hamper attendance at required study visits
• Known latex hypersensitivity
• Current participation in another clinical investigation of a medical device or a drug or participation in such a study within 30 days prior to study enrollment
• Subject appears unwilling or unable to comply with study protocol requirements, including the study treatment and study-related follow-up visit requirements

* Other criteria may apply.

Prostate cancer is the second-leading cause of death in men after lung cancer, accounting for about 10 percent of all cancer-related deaths in men.

Alternative treatment options:

• Cryotherapy
• Radiotherapy
• Prostatectomy