In the present study the clinical feasibility and safety of MR-guided focal boost radiotherapy for patients with locally advanced prostate cancer will be evaluated.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is acute gastrointestinal and genitourinary toxicity,
scored by the Common Terminology Criteria Adverse Events version 5.0.
Secondary outcome
Secondary endpoints are late gastrointestinal and genitourinary toxicity,
quality of life and biochemical disease free survival defined by the Phoenix
consensus definition
Background summary
External beam radiotherapy combined with androgen deprivation therapy is
considered as the treatment of choice for patients with locally advanced
non-metastatic prostate cancer with seminal vesicle invasion. In routine
practice, patients are treated in conventional fractionation schemes (35-40
fractions) or moderate hypofractionation (20 fractions). The long-term results
of the multicentre phase III study (FLAME trial) showed that addition of an
isotoxic focal boost to the intraprostatic lesion improves biochemical disease
free survival in intermediate to high-risk patients without impacting toxicity
and quality of life. This focal boost strategy is now proven for a conventional
fractionation scheme (35 fractions). The current trend in radiotherapy for
prostate cancer is (extreme) hypofractionation, reducing the number of
fractions. For locally advanced prostate cancer, however, the data on extreme
hypofractionation are scarce. There are no long term data available on
combining a hypofractionated schedule with a focal boost.
Study objective
In the present study the clinical feasibility and safety of MR-guided focal
boost radiotherapy for patients with locally advanced prostate cancer will be
evaluated.
Study design
Phase II multicentre intervention study
Intervention
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal
vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to
50Gy to the intraprostatic tumor as visible on multiparametric MRI.
Study burden and risks
The potential risk of participating in the trial is an increase in toxicity,
compared to standard treatment without a focal boost (in 20-40 fractions,
5x/week). The focal boost will be dosed in an isotoxic approach, meaning that
the dose constraints to the organs at risk are leading and the boost dose will
be up to 50Gy or as high as achievable while respecting the dose to the organs
at risk. In the comparable hypoFLAME trial (which excluded patients with
-extensive- seminal vesicle invasion) no grade 3 or higher acute toxicity was
observed. As the constraints to the organs at risk are identical to the
constraints used in the hypoFLAME trial, it is expected that grade 3 of higher
acute toxicity will be less than 5%.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Men aged 18 years or older with histogically proven prostate carcinoma
Imaging stage T3b (as defined on mpMRI) N0M0
Intraprostatic lesion visible on MRI
Capable of giving informed consent
Participation in the MOMENTUM dataregistry
Exclusion criteria
History of radiotherapy to the pelvis or transurethral resection of the
prostate (TURP)
Contraindications for MRI according to the guidelines of the Department of
Radiology, inability to lay on a treatment table for 45-60 minutes or severe
claustrophobia
Absence of pretreatment PSMA PET CT
WHO performance score > 2
International Prostate Symptom Score >= 15
PSA > 30
Prostate volume >100cc
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 |
|---|---|
| CCMO | NL79869.091.22 |