Aim of this study is to investigate the tolerance and the outcome of extreme hypofractionated RT for prostate cancer by delivering a high dose using two alternative time schedules, a short and long treatment interval.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment tolerance and outcome in patients with early stage prostate cancer.
Secondary outcome
Quality of life studies (QOQL, EORTC); local failure; Biochemical disease-free
survival (bDFS); Metastases-free survival; Disease-specific survival.
Background summary
Total dose and dose per fraction play an important role in the curative
treatment with radiotherapy (RT) of prostate cancer. Conventionally
fractionated (2 Gy/fraction) dose escalation above 74 Gy has shown to be
beneficial for prostate cancer.
Prostate cancer cells seem less radiosensitive characterized by a low a/b
ratio.Thus, large treatment fractions (hypofractionation) may increase the
tumor cell killing effect while biologically protecting the surrounding late
responding normal tissues.
Preliminary results from two pilot studies (one with 5-year median follow-up)
on extreme hypofractionation (5 daily fractions of 6.7 and 7.25 Gy over 5 days,
respectively) have been reported. Those patients were treated with stereotactic
beam radiotherapy (SBRT) receiving an equivalent total dose to the tumor in 2
Gy fractions of 78 and 90 Gy, respectively with 5-year biochemical disease
control rates above 90%.
Therefore, there is a need to test the effect on tolerance and outcome of large
fractions delivered in short and long treatment intervals as it is proposed in
the present study: i.e., 5 x 7.25 Gy in 9 days (every other day, qod) versus
the same dose and fractionation but in 28 days (once-a-week). Extreme
hypofractionation for prostate cancer may not only be biologically sound (i.e.,
more cure with less side effects), but also economically advantageous. In fact,
a drop from 40 or more treatments to only 5 sessions, as suggested above, may
significantly reduce the cost of external beam RT. Furthermore, it will
increase the availability of treatment slots in otherwise busy departments, and
finally improve patient*s convenience.
Study objective
Aim of this study is to investigate the tolerance and the outcome of extreme
hypofractionated RT for prostate cancer by delivering a high dose using two
alternative time schedules, a short and long treatment interval.
Study design
Multicenter, prospective randomized clinical phase II study
Intervention
152 patients will be asked to participate. They will be randomized in two
groups. The treatment will be delivered in a short and long treatment intervals
i.e., 5 x 7.25 Gy in 9 days (every other day, qod) versus the same dose and
fractionation but in 28 days (once-a-week). A total of 76 patients will have to
be recruited in each treatment arm.
Study burden and risks
The technique of radiotherapy and the mentioned side-effects are comparable
with the treatment as standard given. During an extra examination,
post-treatment rectal effects will be assessed with a recto-sigmoidoscopy
performed at 18 to 24 months after RT. The chance of perforation or
side-effects of medication needed during scopy are small.
Rue Gabrielle-Perret-Gentil 4
Geneve 14 1211
CH
Rue Gabrielle-Perret-Gentil 4
Geneve 14 1211
CH
Listed location countries
Age
Inclusion criteria
1. Age: adult
2. WHO performance status <= 2
3. Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement <= 20%
4. T-stage: cT1-cT3a
5. Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy
6. Combined hormonal treatment (Neoadjuvant-concomitant hormonal deprivation for 6 months) is mandatory if two or more of the following tumour characteristics are present: >=cT2c, Gleason 4+3, PSA >10 ng/ml, perineural invasion, and/or >1/3 of positive biopsies
7. Concomitant and adjuvant HT for 4 more months
Exclusion criteria
1. Inability to obtain a written informed consent
2. Patient preference to be treated with one rather than the other treatment arm.
3. WHO performance status > 2
4. cT3b,cT4
5. Gleason score >=8
6. Clinical N+ on metastases work-up or N+ risk >20%
7. Severe urinary obstructive symptoms (IPSS symptom index >19)
8. Previous TURP less than 8 weeks before radiotherapy
9. Previous prostate surgery other than TURP
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 | NCT01764646 |
| CCMO | NL41814.029.12 |