NCT03644303: TRAP

Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.

Status unknown NA Last updated 14 November 2019

What this trial tests

NA trial testing SBRT + ADT in Prostate Cancer in 84 participants. Status unknown.

Timeline

13 August 2018

Primary endpoint
1 October 2020

1 October 2021

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	84
Start date	13 August 2018
Primary completion	1 October 2020
Estimated completion	1 October 2021
Sites	7 locations across United Kingdom

Drugs / interventions tested

• SBRT + ADT

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Metastasis — all drugs for Metastasis →
• Toxicity Due to Radiotherapy — all drugs for Toxicity Due to Radiotherapy →
• Circulating Tumour DNA — all drugs for Circulating Tumour DNA →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, male only, with Prostate Cancer or Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Dandelion Dilemma Revisited for Oligoprogression: Treat the Whole Lawn or Weed Selectively?
   Patel PH, Palma D, McDonald F, Tree AC. · · 2019 · cited 79× · PMID 31182289 · DOI 10.1016/j.clon.2019.05.015
2. Stereotactic radiotherapy for oligoprogressive ER-positive breast cancer (AVATAR).
   Alomran R, White M, Bruce M, Bressel M, et al · · 2021 · cited 15× · PMID 33757458 · DOI 10.1186/s12885-021-08042-w
3. Stereotactic Body Radiation Therapy (SBRT) for Oligorecurrent/Oligoprogressive Mediastinal and Hilar Lymph Node Metastasis: A Systematic Review.
   Cozzi S, Alì E, Bardoscia L, Najafi M, et al · · 2022 · cited 13× · PMID 35681659 · DOI 10.3390/cancers14112680
4. Local Therapies in Oligometastatic and Oligoprogressive Prostate Cancer.
   Deek MP, Phillips RM, Tran PT. · · 2021 · cited 11× · PMID 34090651 · DOI 10.1016/j.semradonc.2021.03.007
5. Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer.
   Adorno Febles VR, Blacksburg S, Haas JA, Wise DR. · · 2020 · cited 7× · PMID 32670868 · DOI 10.3389/fonc.2020.00830
6. Metastasis-directed therapy for oligometastatic urological tumours: still no second-hand news.
   Berghen C, Joniau S, Vulsteke C, Albersen M, et al · · 2020 · cited 6× · PMID 32565889 · DOI 10.3332/ecancer.2020.1036