Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
Implant Radiation Therapy or Surgery in Treating Patients With Prostate Cancer
RATIONALE: Receiving standard information and watching a video or DVD at home that describes
 treatment options and treatment outcomes may help patients decide to receive treatment in a
 clinical trial.

 PURPOSE: This randomized clinical trial is studying implant radiation therapy to see how well
 it works compared with surgery in treating patients with prostate cancer.
OBJECTIVES:

 Primary

 -  Determine the proportion of patients consenting to the treatment randomization of
 brachytherapy vs radical prostatectomy in treating patients with good-risk prostate
 cancer.

 -  Determine the feasibility of randomization, in terms of average accrual rate per center,
 during the last 6 months of recruitment.

 Secondary

 -  Determine the decisional quality post-treatment in these patients.

 -  Determine the compliance with allocated treatment in these patients.

 -  Determine the clinical failure in these patients.

 -  Determine the PSA relapse in these patients.

 -  Determine the patient-reported quality of life.

 -  Compare the toxicity of these regimens.

 OUTLINE: This is a multicenter study.

 -  Part 1 (decision-aid randomization): Patients are stratified according to participating
 center. Patients are randomized to 1 of 2 Decision-Aid arms.

 -  Arm I (standard patient information): Patients receive standard patient information
 according to routine clinical practice and preferred materials of each center. This
 information typically includes booklets about prostate cancer and its treatment,
 contact details for sources of further information (e.g., prostate support groups,
 prostate charities, and web-based information), and access to a specialist nurse as
 required.

 -  Arm II (standard patient information + decision aid): In addition to standard
 information as described in Arm I, patients are given a 30-minute Decision-Aid
 video or DVD to take home. The Decision Aid describes the standard treatment
 options available to patients, provides detailed information about treatment
 outcomes in relation to individual patient characteristics, and seeks to help
 patients apply their own personal values to their treatment decision. Patients may
 watch the audio-visual aid as many times as they wish.

 Patients who decide to choose a treatment are removed from study; patients who agree to
 undergo treatment randomization proceed to part 2 of the study.

 -  Part 2 (treatment randomization): Patients are stratified according to risk (low risk vs
 intermediate risk). Patients are randomized to 1 of 2 treatment arms.

 -  Arm I (radical prostatectomy): Patients undergo surgery within 60 days of
 randomization. The surgical technique for radical prostatectomy may be retropubic,
 transperineal, laparoscopic or robotic. Pelvic lymph node surgery is permitted at
 the discretion of the treating surgeon. Unilateral or bilateral nerve-sparing
 techniques may be used at the discretion of the treating surgeon.

 -  Arm II (brachytherapy): Patients undergo brachytherapy within 60 days of
 randomization. Brachytherapy seeds may be implanted using pre-loaded needles or a
 MICK® applicator of either iodine I 125 or palladium Pd 103.

 Patient-reported quality-of-life data is collected to assess erectile function, urinary
 function, bowel function, and general quality of life at baseline and during follow up.

 Patients are followed at 1 and 4 months, every 4 months for 2 years, every 6 months for 3
 years, then annually for 5 years.

 Peer Reviewed and Funded or Endorsed by Cancer Research UK
DISEASE CHARACTERISTICS:

 -  Meeting 1 of the following criteria:

 -  Prostate cancer or suspected prostate cancer confined to the prostate
 (Decision-Aid Randomization)

 -  Clinical stage T1/T2

 -  Due for prostate biopsy or prostate biopsy performed in the last 6 weeks

 -  PSA < 15 ng/mL

 -  Histologically confirmed prostate cancer (Treatment Randomization)

 -  Clinical stage T1/T2

 -  Re-biopsy after a period of active surveillance is at the discretion of the
 treating investigator

 -  Must meet 1 of the following risk criteria (PSA test < 3 months prior to
 treatment intervention):

 -  Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of <
 10 ng/mL

 -  Intermediate risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA
 > 10 ng/mL but ≤ 15 ng/mL

 -  Transrectal ultrasound prostate volume ≤ 50 cc

 PATIENT CHARACTERISTICS:

 -  WHO performance status 0-1

 -  Life expectancy > 10 years (Decision-Aid Randomization)

 -  Satisfactory results from biochemical and hematological profiles that, in the opinion
 of the investigator, does not preclude patient from the trial

 -  No unacceptable risk for radical prostatectomy or prostate brachytherapy

 -  INR < 1.5

 -  No severe lower urinary tract symptoms

 -  No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per
 second, and/or post micturition bladder volume > 100 mL)

 -  No other clinical or medical condition that, in the opinion of the investigator,
 precludes patient from taking part in the trial

 -  No other active malignancy likely to interfere with subsequent protocol treatment and
 follow-up

 PRIOR CONCURRENT THERAPY:

 -  No prior pelvic radiotherapy

 -  No prior abdominoperineal (AP) rectal excision

 -  No prior standard transurethral resection of prostate

 -  No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH
 agonists, or anti-androgens or estrogens)

 -  At least 5 days since prior aspirin or clopidogrel

 -  No concurrent warfarin