To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
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 imaging.
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
• PSA control yearly until 5 years
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.
Study objective
To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing
side effects
Study design
DESTINATION is a single centre phase II non-randomised trial.
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 ADT 8. Patients can be concurrently treated
with androgen deprivation therapy 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
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. High grade disease (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 |
|---|---|
| CCMO | NL82602.041.23 |
| Other | not yet assigned |