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Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer (HERMES)

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ClinicalTrials.gov Identifier: NCT04595019
Recruitment Status : Not yet recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Cancer Research, United Kingdom

Study Description
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Brief Summary:

The purpose of this research is to investigate whether stereotactic body radiotherapy (SBRT), precise X-ray treatment, is best given in five treatments (also called fractions) over 10 days or in two treatments over 8 days. SBRT is an accurate way to deliver a high dose of radiotherapy to the prostate in a smaller number of doses. We have considerable experience with 5-dose SBRT and now wish to examine the feasibility and safety of delivering treatment over two, larger, doses. Previous work has shown it is theoretically possible to deliver two fraction SBRT on the MR-linac and previous studies have shown internal radiotherapy (brachytherapy) administered in two fractions to be a safe option for patients with low-risk prostate cancer.

All treatment within this trial will be delivered on a new, state of the art, radiotherapy machine called an MR-linac (Magnetic Resonance Linear Accelerator). It puts together an MRI scanner with a radiotherapy treatment machine called a Linear Accelerator. The use of the MR-linac means there is no extra radiation dose given when taking images (unlike computerized tomography (CT) scans or X-ray), enabling us to adapt the radiotherapy plan each day if needed to more precisely target the prostate. The results of the study will enable us to find out if the new, shorter treatment (2 doses of radiotherapy), has a similar level of side effects as the 5 dose treatment and is suitable for further study.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: SBRT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centre, randomised phase II trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HERMES Trial Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer. A Phase II Randomised Trial of Ultrahypofractionated Stereotactic Body Radiotherapy in Men With Localised Prostate Cancer
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : April 30, 2028
Estimated Study Completion Date : April 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 5 fraction
MRI-guided radiotherapy, 36.25 Gray (Gy) in 5 fractions (boost to 40 Gy over tumour/prostate CTV) over 10 days.
 Radiation: SBRT
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
Experimental: 2 fraction
MRI-guided radiotherapy, 24 Gy in 2 fractions (boost to 27 Gy over tumour/prostate CTV) over 8 days.
 Radiation: SBRT
Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Genitourinary (GU) toxicity [ Time Frame: 12 weeks ]
    The proportion of patients experiencing CTCAE (Common Terminology Criteria for Adverse Events) Grade 2+ genitourinary (GU) toxicity from the start of radiotherapy up to 12 weeks post-treatment.


Secondary Outcome Measures :
  1. Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) toxicity [ Time Frame: 12 weeks ]
    Physician-reported CTCAE GU and GI toxicity will be reported during treatment and at 12 weeks post-treatment will be summarised according to grade and treatment received using descriptive statistics at each time point.

  2. Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) late toxicity [ Time Frame: 1, 2 and 5 years ]
    Late toxicity (CTCAE) at 1, 2 and 5 years post-treatment will be summarised according to grade and treatment received at each time point.

  3. Quality of life patient-reported outcomes [ Time Frame: 12 weeks, 1, 2 and 5 years post treatment. ]
    Combined data from the IPSS (International Prostate Symptom Score), EPIC-26 (Expanded Prostate Index Composite-26), EQ-5D (EuroQol-5D) and IIEF-5 (International Index of Erectile Function) QOL instruments will be summarised. Domain scores from the quality of life patient-reported outcome tools will be derived using standard algorithms with missing data handled accordingly. Domain scores and individual items from the patient questionnaires will be presented graphically at each time point and summarised using descriptive statistics, separately for each treatment group. Changes from baseline will be assessed within treatment groups, and multiple regression models (e.g. ANCOVA, ordinal logistic regression or longitudinal models) will investigate patient and clinical factors that may be associated with change in patient-reported outcomes.

  4. PSA (Prostate Specific Antigen) control and biochemical failure/progression [ Time Frame: 2 and 5 years ]
    Time to event.


Other Outcome Measures:
  1. Assess bi-parametric MRI prostate imaging parameters during treatment [ Time Frame: 4 and 12 weeks ]
    Descriptive statistics will be used to report and analyse the change in ADC (Apparent diffusion coefficient) between baseline and 4 weeks and between baseline and 12 weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men aged ≥18 years
  2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  3. Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
  4. MRI stage T3a or less
  5. PSA <25 ng/ml prior to starting ADT (Androgen deprivation therapy)
  6. Patients will be concurrently treated with androgen deprivation therapy (ADT) for at least 6 months, as per standard of care. Men who need longer courses of ADT (maximum 12 months) will be considered on a case-by-case basis, and bicalutamide monotherapy is accepted as an alternative to LHRH (luteinizing hormone-releasing hormone) analogues if required.
  7. WHO (World Health Organisation) Performance status 0-2
  8. Ability of the participant understand and the willingness to sign a written informed consent form.
  9. 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. International Prostate Symptom Score (IPSS) 13 or higher
  3. Post-void residual >100 mls
  4. Prostate volume >80cc
  5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
  6. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
  7. Previous pelvic radiotherapy
  8. Patients needing 2-3 years of ADT due to disease parameters.
  9. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595019


Contacts
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Contact: Stephanie Burnett, BSc (Hons) 02087224261 hermes@icr.ac.uk
Contact: Lorna Bower, BSc (Hons) 020 8661 3561 ext 1119 hermes@icr.ac.uk

Locations
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United Kingdom
The Royal Marsden Nhs Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Lorna Bower    020 8661 3561 ext 1119    hermes@icr.ac.uk   
Contact: Sophie Alexander       Sophie.Alexander@rmh.nhs.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
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Study Chair: Alison Tree, BSc, MBBS, FRCR, Royal Marsden NHS Foundation Trust
More Information
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT04595019    
Other Study ID Numbers: ICR-CTSU/2020/10070
CCR5273 ( Other Identifier: Sponsor code )
285291 ( Other Identifier: IRAS ID )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases