Prostate Adenocarcinoma Clinical Trial
— DESTINATIONOfficial title:
A Feasibility Study of Dose De-escalation in Prostate Radiotherapy Using the Magnetic Resonance Linear Accelerator (MRL)
NCT number | NCT05709496 |
Other study ID # | CCR5715 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | March 1, 2027 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2027 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) - MRI-visible tumour(s) of Prostate Imaging-Reporting and Data System (PIRADS) v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology - Tumour nodule visible on MRI occupying <50% of prostate on any axial slice and <50% total prostate volume - PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT) - Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. Luteinizing hormone-releasing hormone (LHRH) analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. - World Health Organisation (WHO) Performance status 0-2 - Ability of the participant understand and the willingness to sign a written informed consent form. - Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study. Exclusion Criteria: - 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 - Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up - Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging - Previous pelvic radiotherapy - Patients needing >6 months of ADT due to disease parameters. - Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden Hospital | Sutton | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The technical ability to treat prostate cancer with escalated dose to the gross tumour volume tumour and de-escalated dose to the normal prostate the Unity MR-linac. | The primary end point is defined by coverage of GTV4mm D90% >42Gy on the post-treatment imaging. | 2 years | |
Secondary | Acute toxicity | Physician reported genitourinary (GU) and gastrointestinal (GI) toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) to be taken at baseline and the end of treatment then at 4 and 12 weeks post-treatment.
The higher the grade the worse the toxicity reported. Each domain will be scored individually. |
2 years | |
Secondary | Late toxicity | Physician reported GU and gastrointestinal (GI) late toxicity (CTCAE) at 1 and 2 years post-treatment.
The CTCAE toxicity will be graded by the physician, with the higher scores equating to worse toxicity. Each domain will be scored individually. |
2 years | |
Secondary | Patient-reported outcomes | Patient-reported outcome measures (PROMs) from the Expanded Prostate Cancer Index Composite-26 (EPIC-26), (International prostate symptom score) IPSS, and International Index of Erectile Function-5 (IIEF-5) questionnaires. Patients will be asked to complete these PROMs at 4 and 12 weeks, 6 months, 1 and 2 years post treatment.
EPIC-26 is scored out of 100, with 100 being the best score. IPPS is made of seven questions with lower scores equating to fewer symptoms. IIEF-5 is composed of 5 questions, the highest score of 25 is indicative of severe erectile dysfunction |
2 years | |
Secondary | Biochemical control | The trend in PSA will be measured up until two years. An increase in the PSA is suggested of biochemical failure and disease relapse | 2 years |
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