Hypofractionated Expedited Radiotherapy for Men With localisEd proState Cancer

NCT04595019 | Recruiting DMC

• 3 other identifiers: ICR-CTSU/2020/10070CCR5273285291
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

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

  12 weeks

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

  1, 2 and 5 years

• Quality of life patient-reported outcomes

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

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

  2 and 5 years

Other Outcomes (1)

• Assess bi-parametric MRI prostate imaging parameters during treatment

  4 and 12 weeks

Study Arms (2)

5 fraction

ACTIVE COMPARATOR

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

Radiation: SBRT

2 fraction

EXPERIMENTAL

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

Radiation: SBRT

Interventions

SBRT RADIATION

Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.

2 fraction; 5 fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

The Royal Marsden Nhs Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alison Tree, BSc, MBBS, FRCR,

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Stephanie Burnett, BSc (Hons)

CONTACT

02087224261; hermes@icr.ac.uk

Lorna Bower, BSc (Hons)

CONTACT

020 8661 3561; hermes@icr.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre, randomised phase II trial

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: October 20, 2020
• Study Start: July 29, 2021
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 13, 2022

Record last verified: 2022-06

Locations

GB (1)