To develop a 5 fraction de-escalated dose SBRT protocol potentially capable of reducing side effects intended for prostate cancer patients with empty bladder
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Technical feasibility of treating prostate cancer with toxicity-minimising
radiotherapy on an MR-linac. Feasibility is defined as coverage of GTV boost
D90% >42Gy on the post-treatment MRI.
Secondary outcome
• Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at
baseline and the end of treatment then at 4 weeks and 3 months post-treatment.
• Late toxicity (CTCAE) at 1 and 2 years post-treatment
• Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5
questionnaires.
Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2
years post treatment.
• PSA control and kinetics at 2 years post-treatment
Background summary
The prognosis of low and intermediate risk localized prostate cancer after
surgery, radiotherapy or brachytherapy is excellent. Therefore, when choosing a
treatment modality, the side effects are becoming increasingly important and
research is focussed on a reduction in side effects.
To eradicate all tumour, external beam radiotherapy traditionally irradiates
the tumour and the entire prostate to the full dose, including a safety margin
around the prostate. This means that a volume of healthy tissue is also
irradiated, which causes the side effects of radiotherapy. Reducing the dose of
healthy tissue that is irradiated leads to fewer side effects.
The side effects of external beam radiotherapy have been reduced due to
continuous, iterative improvements in radiotherapy delivery technology. This
has allowed us to harness the power of modern computing and discoveries in
clinical physics, to create radiotherapy doses which conform very tightly to
the edge of the prostate. This results in vastly less dose to the normal,
healthy tissues around the cancer. The ultimate evolution of this progress is
the MR-linac, a new radiotherapy machine which offers more precise dose
delivery than ever before.
This study aims to investigate the benefit of MRI-guided adaptive SBRT,
targeting dose where we know it is needed and reducing dose where the
risk-benefit ratio suggests healthy tissue can be safely spared.
Up to now, to keep the dose to the bladder low and prevent side effects usually
prostate radiotherapy is done with filled bladders. To limit anatomical changes
and reduce the variation in bladder filling, in current clinical practice
drinking protocols are applied, that instruct the patient to void the bladder
and drink a fixed amount of liquid at a specified time prior to each treatment
fraction. The effectiveness of such protocols is however quite disappointing ,
while the procedures cause considerable patient anxiety. Moreover, the filling
of the bladder during the course of the fraction gives extra rise to
intra-fraction motion, potentially reducing the accuracy of the treatment. With
MRI-guided radiotherapy, especially with the DESTINATION treatment protocol,
the dose to surrounding structures including the bladder is substantially
reduced. This means that a filled bladder during treatment is probably no
longer necessary.
Study objective
To develop a 5 fraction de-escalated dose SBRT protocol potentially capable of
reducing side effects intended for prostate cancer patients with empty bladder
Study design
Single centre non-randomised feasibility study
Intervention
Radiotherapy
Study burden and risks
Although we do not expect it, more recurrences may occur after the DESTINATION
treatment. In view of reported experiences in the literature, the probability
of this is very limited.
The additional burden for the patient is the 7 x completion of 3
questionnaires. The follow-up moments in the trial coincide with the regular
follow-up moments.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. Men aged >=18 years
2. Histological confirmation of prostate adenocarcinoma requiring radical
radiotherapy
3. Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
4. MRI stage T2 or less (as staged by AJCC TNM 2018)
5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and
diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with
concordant pathology
6. Dominant lesion <50% of prostate on any axial slice and <50% total prostate
volume
7. PSA <20 ng/ml prior to starting Androgen Deprivation Therapy (ADT).
8. Patients can be concurrently treated with ADT if this would be standard of
care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where
this would usually be omitted.
9. WHO Performance status 0-2
10. Ability of the participant understand and the willingness to sign a written
informed consent (IC) form.
11. Ability/willingness to comply with the patient reported outcome
questionnaires schedule throughout the study.
Exclusion criteria
1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant,
claustrophobia)
2. IPSS 19 or higher
3. biopsies >=GG3 occult to MRI-defined lesion
4. Post-void residual >100 mls, where known
5. Prostate volume >90cc
6. Comorbidities which predispose to significant toxicity (e.g. inflammatory
bowel disease) or preclude long term follow up
7. Unilateral or bilateral total hip replacement, or other pelvic metalwork
which causes artefact on diffusion-weighted imaging
8. Previous pelvic radiotherapy
9. Patients needing >6 months of ADT due to disease parameters.
10. Previous invasive malignancy within the last 2 years excluding basal or
squamous cell carcinomas of the skin, low risk non-muscle invasive bladder
cancer (assuming cystoscopic follow up now negative) or small renal masses on
surveillance.
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 |
|---|---|
| Other | in progress |
| CCMO | NL87118.041.24 |