At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac (radiation)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- De-escalated radiotherapy to be delivered on the Elekta Unity Unity MR-linac — radiation: 30 Gy in 5 fractions to the whole prostate with 45 Gy in 5 fractions to the dominant lesion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 20
- Started
- 2023-03-01
- Last checked
- 2024-04
Plain English Summary
What is this study?
- • Testing a new treatment for prostate adenocarcinoma
- • NA - 20 participants
- • The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate adenocarcinoma
- • Male only
Where?
- • Sutton - The Royal Marsden Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this feasibility study is to learn about dose de-escalation in the treatment of men with intermediate risk prostate cancer. The main question it aims to answer is the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an Magnetic Resonance Linear Accelerator (MR-linac). It will also examine gastrointestinal and genitourinary toxicity in the acute and late setting post radiotherapy as well as Prostate-Specific antigen (PSA) control up until 2 years post treatment. Participants will be treated with radiotherapy to the prostate with which will be given in 30Gy in 5 fractions to the whole prostate and 45Gy in 5 fractions to the dominant lesion.
More detail
DESTINATION is a single centre phase II non-randomised study in men with intermediate risk localised prostate cancer. The aim is to establish the technical feasibility of treating prostate cancer with toxicity-minimising radiotherapy on an MR-linac. 20 men will be recruited to take part. All radiotherapy will be delivered on the MR-linac. The whole prostate with no margin will be treated to 30 Gray (Gy) in 5 fractions (i.e. dose to 95% of the Clinical Target Volume prostate should receive 30 Gy (D95%CTVp= 30 Gy)). The dominant lesion (Gross tumour volume (GTV)) as defined on pre-biopsy multiparametric magnetic resonance imaging (mpMRI) plus a 4mm intra-prostatic margin (GTV4mm) will be treated to 45 Gy in 5 fractions, providing standard organ at risk (OAR) constraints can be met. If not, then dose coverage of the GTV will be reduced until the OAR constraints are met (i.e. isotoxic dose escalation). OAR constraints will be as per international standard levels, and largely consistent with the PACE B trial. The primary end point will be assessed once 14 patients have completed their radiotherapy treatment on the MR-Linac. If any of the first 14 patients do not complete all five fractions planned, then recruitment will continue until we have 14 assessable patients. The analysis population for the primary endpoint will be defined as those patients who have completed all five fractions of stereotactic body radiotherapy (SBRT) as intended. If shown to be feasible a total of 20 patients will be recruited to enable a better estimation of the toxicity rates and to further technical proficiency with this technique.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
Biomarkers mentioned
What the study is looking for
- ✓Men aged ≥18 years
- ✓Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- ✓Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- ✓MRI stage T2 or less (as staged by AJCC TNM 2018)
- ✓Tumour nodule visible on MRI occupying \<50% of prostate on any axial slice and \<50% total prostate volume
Who cannot take part
- ✗Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- ✗IPSS 19 or higher
- ✗High grade disease (GG3) occult to MRI-defined lesion
- ✗Post-void residual \>100 mls, where known
- ✗Prostate volume \>90cc
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Alison Tree, MBBS
Sponsor contactCONTACT
Rosalyne L Westley, MBchB
Sponsor contactCONTACT
