Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
18 Years
N/A
Male
Prostate Cancer
Trial Information
Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study
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
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label
Outcome Measure:
Proportion of patients consenting to the treatment randomization
Safety Issue:
No
Principal Investigator
David Bottomley
Investigator Role:
Principal Investigator
Investigator Affiliation:
Leeds Cancer Centre at St. James's University Hospital
Authority:
Unspecified
Study ID:
CDR0000668741
NCT ID:
NCT01098331
Start Date:
May 2009
Completion Date:
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
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