Radiotherapy treatment options for men with localized prostate cancer

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

This study is testing whether a new way of giving radiation therapy in fewer sessions can safely help men with localized prostate cancer feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Institute of Cancer Research, United Kingdom (other)
• Drugs / interventions: radiation
• Locations: 1 site (Sutton, Surrey)
• Trial ID: NCT04595019 on ClinicalTrials.gov

What this trial studies

This research investigates the effectiveness of stereotactic body radiotherapy (SBRT) for men with localized prostate cancer, comparing two treatment regimens: five treatments over ten days versus two larger treatments over eight days. The study utilizes a state-of-the-art MR-linac machine, which combines MRI imaging with radiotherapy delivery, to ensure precise targeting of the prostate. The aim is to assess the feasibility and safety of the two-fraction approach, building on previous findings that suggest it may be a viable option for patients with low-risk prostate cancer.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with histologically confirmed prostate adenocarcinoma requiring radical radiotherapy and specific Gleason scores.

Not a fit: Patients with contraindications to MRI or those with advanced prostate cancer beyond the specified MRI stage may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more efficient and effective radiotherapy regimen for men with localized prostate cancer, potentially reducing treatment time and improving patient outcomes.

How similar studies have performed: Previous studies have shown success with similar approaches, particularly in the use of two-fraction internal radiotherapy for low-risk prostate cancer.

Eligibility 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.

Where this trial is running

Sutton, Surrey

• The Royal Marsden Nhs Foundation Trust — Sutton, Surrey, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Stephanie Burnett, BSc (Hons)

Conditions: Prostate Cancer