NCT03644303

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

2.1 years

First QC Date

August 15, 2018

Last Update Submit

November 13, 2019

Conditions

Prostate CancerMetastasisToxicity Due to RadiotherapyCirculating Tumour DNA

Outcome Measures

Primary Outcomes (1)

  • Median Progression-Free Survival (PFS)

    Median progression free survival following SBRT to oligo-progressing metastatic sites assessed using the RECIST (v 1.1) criteria on imaging such as computed Tomography (CT),bone scan, magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scan

    Outcome to be assessed at 6 months from end of SBRT

Secondary Outcomes (5)

  • Local control rate following SBRT

    Outcome to be assessed at 6 months and 1 year from end of SBRT

  • Incidence and severity of treatment induced symptoms

    From the start of SBRT up to 24 months following delivery of SBRT

  • Health Related Quality of Life

    Change from start of radiotherapy to each time-point including 3 and 6 months after end of SBRT

  • Time to administration of next line of therapy

    From the end of SBRT up to 24 months following delivery of SBRT

  • Association between selected WB DW MRI characteristics at baseline and prognosis after SBRT

    Outcome to be assessed at 6 months and 1 year from end of SBRT

Other Outcomes (1)

  • Exploration of novel bio-markers to assess response to SBRT treatment

    Assessment of Progression Free Survival at 6 months and 1 year

Study Arms (1)

SBRT + ADT

EXPERIMENTAL

Enzalutamide OR Abiraterone at licensed doses in combination with stereotactic radiotherapy: 30 Gray in 5 fractions

Radiation: SBRT + ADT

Interventions

SBRT + ADTRADIATION

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

Also known as: Enzalutamide or Abiraterone plus stereotactic radiotherapy
SBRT + ADT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and able to provide written informed consent for the trial and be ≥18 years of age on day of signing informed consent.
  • Have metastatic Castration Resistant Prostate Cancer (CRPC) based on biochemical or pathological diagnosis and be on Enzalutamide or Abiraterone.
  • Have had a minimum of 6 months on Enzalutamide or Abiraterone with evidence of response (PSA, radiological or symptomatic)
  • Have 1 - 2 metastatic lesions progressing on imaging (CT, bone scan, MRI or other local imaging) or a clinical or imaging diagnosis of progression of a non-irradiated primary site with the remainder of their metastases currently controlled by Enzalutamide or Abiraterone.
  • Have had no previous radical radiation to the index area (defined as unable to deliver SBRT doses in this protocol without taking normal tissues beyond tolerance).
  • Have a Performance Status (PS) assessed using the Eastern Co-operative Oncology Group (ECOG) criteria of 0 - 1.
  • Have an oligoprogressing site, including those that have developed on treatment, in bone, lymph node, prostate or lung but not in liver, brain, adrenal or other sites.
  • Patients may be symptomatic in the oligoprogressing area. However, there is no urgent need to start radiotherapy.

You may not qualify if:

  • A clinical need exists to switch therapy immediately (e.g. suspicion of rapid clinical progression, urgent need for palliative radiotherapy).
  • Evidence of previous invasive cancer in the last 5 years, with the exception of non-melanoma skin cancer (non-invasive malignancies such as non-muscle invasive bladder cancer are not excluded).
  • There is a contra-indication to radiotherapy (e.g. inflammatory bowel disease).
  • There is a contra-indication to MRI where required for radiotherapy (e.g. cardiac pacemaker, internal defibrillator, shrapnel injury or claustrophobia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Christie NHS Foundation Trust

Manchester, Manchester Greater, M20 4BX, United Kingdom

NOT YET RECRUITING

Belfast Health & Social care Trust

Belfast, Northern Ireland, BT8 8BH, United Kingdom

NOT YET RECRUITING

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM5 3EZ, United Kingdom

RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

NOT YET RECRUITING

Velindre Cancer Centre

Cardiff, Wales, CF14 2TL, United Kingdom

NOT YET RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

NOT YET RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

NOT YET RECRUITING

Related Publications (1)

  • Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.

    PMID: 34903471DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

RadiosurgeryAndrogen Antagonistsenzalutamideabiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative TechniquesHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Alison Tree, FRCR

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Wedlake, PhD

CONTACT

+44 208 915 6767linda.wedlake@rmh.nhs.uk

Victoria Pittordou, BSc

CONTACT

+ 44 208 915 6766victorai.pittordou@rmh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Interpretation of the two paired WB DW MRI scans (baseline and 6 months) will be conducted by one assessor will be blinded to the identity of the baseline scan to ensure minimisation of any potential bias.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm, prospective interventional cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2018

First Posted

August 23, 2018

Study Start

August 13, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

November 14, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Human tissue (blood) in surplus will be made available for other ethically approved research provided patients have given their informed consent

Time Frame
Not anticipated to be before 6 months have elapsed following recruitment of the last patient.
Access Criteria
On provision of written request

Locations

GB(7)