Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.

NCT03644303 | Completed Results DMC

• 1 other identifier: CCR 4781
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Median Progression-Free Survival (PFS)

  Median progression free survival following SBRT to progression, starting new treatment or death from any cause. Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.

  Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

Secondary Outcomes (13)

• Progression-Free Survival (PFS) Events

  Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

• Progression-Free Survival (PFS) Estimates

  Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

• Local Control Rate Following SBRT

  At the 6 month timepoint from end of SBRT

• Median Overall Survival (OS)

  Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

• Overall Survival (OS) Events

  Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

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 + ADT RADIATION

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

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (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).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Prostate Cancer UK: collaborator
• University College, London: collaborator
• The Christie NHS Foundation Trust: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Velindre NHS Trust: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Belfast Health and Social Care Trust: collaborator

Study Sites (7)

The Christie NHS Foundation Trust

Manchester, Manchester Greater, M20 4BX, United Kingdom

Location

Belfast Health & Social care Trust

Belfast, Northern Ireland, BT8 8BH, United Kingdom

Location

Angelie Tirona

Sutton, Surrey, SM5 3EZ, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

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

Location

Velindre Cancer Centre

Cardiff, Wales, CF14 2TL, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

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: 34903471 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Radiosurgery; Androgen Antagonists; enzalutamide; abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Clinical Trials Manager - Angelie Tirona
• Organization: The Royal Marsden NHS Foundation Trust

Trap.Trial@rmh.nhs.uk

020 8642 6011

Study Officials

• Alison Tree, FRCR

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, prospective interventional cohort study

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 23, 2018
• Study Start: August 13, 2018
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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)