Back to results

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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

SBRT

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Men aged ≥18 years
Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
Gleason score 3+4 or 4+3 (Grade groups 2 or 3)
MRI stage T3a or less
PSA <25 ng/ml prior to starting ADT (Androgen deprivation therapy)
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.
WHO (World Health Organisation) 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)
International Prostate Symptom Score (IPSS) 13 or higher
Post-void residual >100 mls
Prostate volume >80cc
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 2-3 years 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 cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.

Sites / Locations

The Royal Marsden Nhs Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5 fraction

2 fraction

Arm Description

MRI-guided radiotherapy, 36.25 Gray (Gy) in 5 fractions (boost to 40 Gy over tumour/prostate CTV) over 10 days.

MRI-guided radiotherapy, 24 Gy in 2 fractions (boost to 27 Gy over tumour/prostate CTV) over 8 days.

Outcomes

Primary Outcome Measures

Genitourinary (GU) toxicity

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

Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) toxicity

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.

Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) late toxicity

Late toxicity (CTCAE) at 1, 2 and 5 years post-treatment will be summarised according to grade and treatment received at each time point.

Quality of life patient-reported outcomes

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.

PSA (Prostate Specific Antigen) control and biochemical failure/progression

Time to event.

Full Information

NCT ID

NCT04595019

First Posted

July 24, 2020

Last Updated

June 9, 2022

Sponsor

Institute of Cancer Research, United Kingdom

1. Study Identification

Unique Protocol Identification Number

NCT04595019

Brief Title

Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

Acronym

HERMES

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2021 (Actual)

Primary Completion Date

April 30, 2028 (Anticipated)

Study Completion Date

April 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Cancer Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single centre, randomised phase II trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5 fraction

Arm Type

Active Comparator

Arm Description

MRI-guided radiotherapy, 36.25 Gray (Gy) in 5 fractions (boost to 40 Gy over tumour/prostate CTV) over 10 days.

Arm Title

2 fraction

Arm Type

Experimental

Arm Description

MRI-guided radiotherapy, 24 Gy in 2 fractions (boost to 27 Gy over tumour/prostate CTV) over 8 days.

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.

Primary Outcome Measure Information:

Title

Genitourinary (GU) toxicity

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) toxicity

Description

Time Frame

12 weeks

Title

Physician-reported CTCAE Genitourinary (GU) and Gastrointestinal (GI) late toxicity

Description

Late toxicity (CTCAE) at 1, 2 and 5 years post-treatment will be summarised according to grade and treatment received at each time point.

Time Frame

1, 2 and 5 years

Title

Quality of life patient-reported outcomes

Description

Time Frame

12 weeks, 1, 2 and 5 years post treatment.

Title

PSA (Prostate Specific Antigen) control and biochemical failure/progression

Description

Time to event.

Time Frame

2 and 5 years

Other Pre-specified Outcome Measures:

Title

Assess bi-parametric MRI prostate imaging parameters during treatment

Description

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.

Time Frame

4 and 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men aged ≥18 years Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy Gleason score 3+4 or 4+3 (Grade groups 2 or 3) MRI stage T3a or less PSA <25 ng/ml prior to starting ADT (Androgen deprivation therapy) 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. WHO (World Health Organisation) 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) International Prostate Symptom Score (IPSS) 13 or higher Post-void residual >100 mls Prostate volume >80cc 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 2-3 years 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 cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephanie Burnett, BSc (Hons)

Phone

02087224261

hermes@icr.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Lorna Bower, BSc (Hons)

Phone

020 8661 3561

Ext

1119

hermes@icr.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Tree, BSc, MBBS, FRCR,

Organizational Affiliation

Royal Marsden NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

The Royal Marsden Nhs Foundation Trust

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lorna Bower

Phone

020 8661 3561

Ext

1119

hermes@icr.ac.uk

First Name & Middle Initial & Last Name & Degree

Sophie Alexander

Sophie.Alexander@rmh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

We'll reach out to this number within 24 hrs