Clinical trial NCT01890096: A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Official title: A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma of the Prostate
Keywords: HDR
monotherapy
low
intermediate
prostate cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 174
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed diagnosis of adenocarcinoma of the prostate
* low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA \< 20ng/mL. PSA to be drawn within 60 days of registration
* prostate volume \< 60 cc as determined by ultrasound, CT or MRI
* willing to give informed consent ot participate in this clinical trial
* able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

* documented nodal or distant metastases
* previous pelvic radiotherapy
* previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
* use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
* poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
* significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Primary outcomes:
measure: Health related quality of life (QoL)
timeFrame: 1 year
Secondary outcomes:
measure: GU and GI toxicities
timeFrame: baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
measure: Urinary Symptoms
timeFrame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
measure: Serum PSA changes
timeFrame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
measure: Biochemical failure and disease free survival rates
timeFrame: 5 years
measure: Erectile function
timeFrame: 5 year
measure: Associations between dosimetric parameters and toxicity/EPIC domains
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gerard Morton, MD
role: PRINCIPAL_INVESTIGATOR
References: