- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To decrease the five-year biochemical relapse rate with at least 10%.
Secondary outcome
Does the addition of an ablative microboost to the macroscopic tumour within
the prostate change treatment related toxicity, quality of life or disease free
survival.
Background summary
Dose escalation in external-beam irradiation has proven to benefit outcome in
local prostate cancer. Randomized trials were performed up to doses of 78 Gy in
2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was
approximately 35% in the high-dose arm. Therefore further dose escalation seems
to be required. A feasibility study up to appr. 85 Gy on the entire prostate
has already been performed and showed acceptable toxicity when combined with
adequate position verification. Higher doses to the entire prostate are
expected to increase severe toxicity. As local recurrences only occur at the
site of the primary macroscopic tumour area the next step in increasing the
dose should be an ablative boost to the macroscopic tumour alone, while
electively irradiating the rest of the prostate to the current gold standard
dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy
to the macroscopic tumour within the prostate.
Study objective
- Primary study objective: To demonstrate the superiority of the ablative
microboost dose schedule regarding 5-year biochemical no evidence of disease
rate compared to the current standard of care.
- Secondary study objectives: Establish and compare the rates of
treatment-related toxicity, quality of life and disease-free survival.
Study design
Single blind prospective randomized controlled phase III trial.
Intervention
The standard arm receives the current gold standard, namely 77Gy to the
prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm
patients receive in addition to the current gold standard of 77 Gy to the
prostate an integrated boost to the macroscopically visible tumour to reach a
total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
Study burden and risks
Patients will have to fill in a quality of life questionnaire before and after
the radiotherapy treatments.
The risk associated with the increased dose to the macroscopic tumour is an
increase of toxicity and a reduction of quality of life.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with intermediate or high risk local prostate cancer
WHO 0-2
Exclusion criteria
Low risk prostate cancer
WHO score >2
If an MRI cannot be performed
IPSS score >20
Previous pelvic irradiation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01168479 |
| CCMO | NL26038.041.08 |