Carcinoma of the Prostate
Conditions
Keywords
HDR, monotherapy, low, intermediate, prostate cancer
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.
Interventions
RADIATIONHDR 2 Fraction
High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.
RADIATIONHDR 1 Fraction
High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life (QoL) | 1 year | To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Symptoms | baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years | To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS) |
| Serum PSA changes | baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years | To determine changes in serum prostate-specific antigen (PSA) in both arms |
| GU and GI toxicities | baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years | To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 |
| Erectile function | 5 year | To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale |
| Associations between dosimetric parameters and toxicity/EPIC domains | 5 years | To explore association between dosimetric parameters and toxicity/EPIC domain change |
| Biochemical failure and disease free survival rates | 5 years | To determine PSA failure and disease free survival rates in both study arms |
Countries
Canada
Outcome results
None listed