To assess non-inferiority of treating patients with localized, intermediate risk prostate cancer in two fractions of 12 Gray (Gy) with a boost to the gross tumor volume of 13.5 Gy per fraction in 8 days, as compared to standard care (36.25 Gy in…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Genitourinary tract disorders NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
difference in proportion of participants with acute (within 12 weeks after
start radiotherapy) CTCAE grade 2 or higher genitourinary toxicity
Secondary outcome
• To assess physician reported toxicity (CTCAE) other than acute GU toxicity
• To assess patient reported outcome measures (PROMs), using the following
validated instruments:
o EORTC-QLQ-C30 (general quality of life for patients who undergo/underwent
oncological treatment)
o EQ-5D (cost-effectiveness and general QoL)
o EORTC-QLQ-PR25 (prostate-related quality of life after oncological therapy)
• To assess biochemical progression free survival and time to relapse, through
evaluation of PSA control and kinetics.
Background summary
Hypofractionation in prostate cancer radiotherapy has already led to a drastic
reduction in fractionation scheme from 35 fractions to the now standard 5
fractions for patients with intermediate risk prostate cancer. Currently,
biochemical progression free survival is at approximately 90% at five-year
follow-up for intermediate risk prostate cancer patients, which leaves little
to no room for further improvement in oncological outcomes. However, with an
ageing population and a subsequently higher volume of patients with localized
prostate cancer, there is a need to improve and optimize current treatment
options. Treatment cost within the field of prostate oncology will further
increase over the years to come, and an early economic health evaluation has
demonstrated that a 2-fractionation scheme with MRI-guided radiotherapy (MRgRT)
for intermediate risk prostate cancer patients can be cost effective compared
to the standard of care 5 fractions scheme if adverse effects due to the
treatment and operational costs are reduced..
Previous research demonstrated the feasibility of delivering high doses of
radiation in only two fractions, both in silico as well as in a clinical
setting using a conventional CT-guided linear accelerator. With the
introduction of MRgRT, however, it has become possible to deliver higher doses
of radiation with more accuracy, while limiting genitourinary (GU) and
gastrointestinal (GI) toxicity. This leads us to believe that improvements can
be made both in terms of costs as well as patient reported quality of life
Study objective
To assess non-inferiority of treating patients with localized, intermediate
risk prostate cancer in two fractions of 12 Gray (Gy) with a boost to the gross
tumor volume of 13.5 Gy per fraction in 8 days, as compared to standard care
(36.25 Gy in five fractions in 16-18 days), on an ELEKTA Unity MR-Linac system.
Study design
single center, open label, phase II randomized clinical trial
Intervention
Radiotherapy on the MR-Linac system, two fractions of 12 Gy with a boost on
the tumor of 13.5 Gy each time, delivered in eight days.
Study burden and risks
Participants will receive QOL questionnaires which are already embedded within
the MOMENTUM-study. Therefore, participants are not subjected to an additional
burden during the course and follow-up period of this study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 years
• Histopathological confirmation of prostate adenocarcinoma requiring radical
treatment
• Intraprostatic tumor visible and delineable on diagnostic imaging
• EAU intermediate risk prostate cancer
o PSA < 20 ng/ml
o Gleason score <= 7
o cT1c-cT2b/iT3a (non-bulky, < 20mm)
• Written informed consent
• Informed consent to share medical data and fill out quality of life
questionnaires in the MOMENTUM study.
Exclusion criteria
• Contraindication to MRI (e.g., pacemaker)
• IPSS 15 or higher
• Prostate volume > 80 cc
• Comorbidities which predispose to significant toxicity (e.g., inflammatory
bowel disease)
• Metal pelvic implants which cause artefact on MR-imaging sequences (e.g.,
total hip replacement)
• Previous radical prostatectomy
• Previous pelvic radiotherapy
• Previous invasive malignancy within the last 5 years, excluding basal cell
carcinoma of the skin
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 | NL85364.041.23 |