The aim of the present phase II Hypo-FLAME 2.0 study is to investigate whether it is feasible and safe (acceptable acute toxicity) to further reduce the Overall Treatment Time of whole gland SBRT with a simultaneous integrated focal boost for…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute gastrointestinal and genitourinary toxicity, scored using 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 is one of the standard treatment options for
patients with prostate cancer. The overall treatment time of a standard
fractionated schedule varies between 7 and 8 weeks (i.e. 35-40 fractions,
5x/week). Recent studies have identified a proportionally longer overall
treatment time as a potential adverse factor for treatment outcome in prostate
cancer patients who were treated by conventional radiotherapy schedules.
Furthermore shortening of the overall treatment time promotes patient
convenience. An extreme shortening of the overall treatment time is possible by
using hypofractionated treatment schedules with simultaneous integrated
intraprostatic tumor boosting to overcome local recurrences*
Study objective
The aim of the present phase II Hypo-FLAME 2.0 study is to investigate whether
it is feasible and safe (acceptable acute toxicity) to further reduce the
Overall Treatment Time of whole gland SBRT with a simultaneous integrated focal
boost for prostate cancer
Study design
Multicenter, single arm phase II study
Intervention
Radiotherapy with simultaneous integrated boost
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 this trial is an increase
in toxicity. Since in the current protocol only a small part of the prostate
receives an increased dose, unacceptable higher toxicity to the organs at risk
is not expected. Furthermore, to achieve equal or less toxicity compared to the
current radiotherapy protocols, the dose to the organs at risk will be
prioritized. Besides, in the original Hypo-FLAME study no > grade 2 acute
toxicity has been observed (unpublished data). Hence, this study is considered
as a low-risk trial.
Herestraat 49
Leuven B 3000
BE
Herestraat 49
Leuven B 3000
BE
Listed location countries
Age
Inclusion criteria
- Men >= 18 years with histologically confirmed prostate adenocarcinoma
- Intermediate- or high-risk PCa, defined as at least one of the following risk
criteria:
- Clinical stage: T2b, T2c, T3a or T3b with less than 5 mm invasion in the
seminal vesicles (defined on MRI) N0 M0
- Gleason sum score >= 7
- PSA >= 10 ng/mL.
- Prostate tumor nodule visible on mpMRI
- Ability to give written informed consent and willingness to return for
follow-up
Exclusion criteria
- Prior pelvic radiotherapy or transurethral prostate resection
- Unsafe to have gold fiducial marker implantation, if gold fiducial markers
are used for image guidance (non MR-linac)
- Contraindications to MRI according to the Radiology Department guidelines
(metal implants, non-compatible cardiac device, allergy to gadolinium, severe
renal dysfunction or severe claustrophobia)
- World Health Organization (WHO) performance score > 2
- International prostate symptoms score (IPSS score) >= 15
- PSA > 30 ng/mL
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 | NCT04045717 |
| CCMO | NL71504.031.19 |