Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.

Summary

This multi-center, phase II trial will be conducted in men with castration resistant prostate cancer. The aim of the TRAP trial is to test whether a new precise radiotherapy technique called stereotactic body radiotherapy (SBRT) can slow down the growth of metastatic prostate cancer. If SBRT is effective it will represent a new treatment option in these patients, providing more prolonged control without having to resort to chemotherapy and its potentially unpleasant side effects.

In this trial, the investigators will identify men who, despite being on next generation androgen deprivation treatment (Abiraterone or Enzalutamide) have developed one or two new sites of worsening (growing) disease but the rest of their cancer is still responding to hormonal therapy. If it is the case that SBRT can successfully treat the cancer which is resistant to current treatment then the investigators hope they will be able to better control the spread of cancer in these patients for longer.

The investigators also hope that they will be able to use the tell-tale products (gene markers) that are released into the bloodstream in these patients, or identify characteristics on novel imaging such as magnetic resonance imaging (MRI) to help identify patients in the future who will benefit the most.

Conditions

• Prostate Cancer
• Metastasis
• Toxicity Due to Radiotherapy
• Circulating Tumour DNA

Interventions

RADIATION

SBRT + ADT

Short course SBRT to 1 or 2 oligo-progressing metastases in addition to continued abiraterone or enzalutamide

Sponsors & Collaborators

• Prostate Cancer UK

  collaborator OTHER

• University College, London

  collaborator OTHER

• The Christie NHS Foundation Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Velindre NHS Trust

  collaborator OTHER_GOV

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Belfast Health and Social Care Trust

  collaborator OTHER

• Royal Marsden NHS Foundation Trust

  lead OTHER

Principal Investigators

• Alison Tree, FRCR · Royal Marsden NHS Foundation Trust

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-13

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• United Kingdom

Study Locations