Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasm Metastasis

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

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

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

SBRT + ADT

Linda Wedlake, PhD

Victoria Pittordou, BSc

Ananya Choudhury, PhD

Suneil Jain

L J Wedlake, PhD

V J Pittordou, BSc

Alison Tree, FRCR

Gerhardt Attard, PhD

NIna Tunariu, PhD

Nicholas VanAs, MBBS

John Frew, MBBS

John Staffurth, MBBS

Daniel Ford, MBBS

Ann Henry, PhD

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.

For many men with metastatic prostate cancer, the cancer develops resistance to successive systemic therapies and eventually all treatment options are exhausted and the patient succumbs to their disease. It is therefore vital to find ways of evading prostate cancer resistance. Stereotactic body radiotherapy (SBRT) has the advantage that it destroys cancerous tissue irrespective of the underlying genetic deficit within the progressing metastasis. If the resistant clones are localized to 1-2 metastases and can be destroyed or ablated, the patient can continue to receive the benefit of their systemic (androgen deprivation) treatment (Abiraterone or Enzalutamide) which may continue to control the remainder of their disease for many months, possibly even years.

SBRT is a recognised technique for the elimination of isolated metastases in other tumour sites achieving local control of metastasis in 80-90% of cases. This is achieved with very few side effects. In the TRAP trial, the investigators wish to establish whether it is beneficial to target 1 or 2 metastatic sites with SBRT or whether patients will develop polymetastatic progression. Patients enrolled on the trial will receive 30 Gy in 5 fractions on alternate days over 10 days. They will continue their androgen deprivation treatment throughout and following SBRT. Side effects will be closely monitored throughout and patients will be seen at the end of radiotherapy and then 4 weeks after treatment. Thereafter patients will undergo trial follow up three monthly which will includes Prostate Specific Antigen (PSA) monitoring.

In addition to the above procedures, the investigators will use a combination of whole body (WB) diffusion weighted (DW) magnetic resonance imaging (WB DW MRI) and circulating tumour (ct) deoxyribonucleic acid (DNA), 'ct DNA' biomarker analysis with the aim of identifying those patients which benefit most from the combination of SBRT and androgen deprivation treatment. WB DW MRI is a novel MRI technique which shows improved sensitivity compared to standard MRI. The marker ctDNA enables the investigators to explore genomic characterisation and variation of metastases and compare findings with previously explored genome mutations in prostate cancer patients.

Single arm, prospective interventional cohort study

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.

Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.

TRAP - Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.

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

Levels of circulating tumor Deoxyribonucleic Acid (ctDNA)

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

Overall control defined as stable disease or partial response of irradiated metastases assessed using the RECIST (v 1.1) criteria on imaging such as computed Tomography (CT), magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scan or control on bone scan

Incidence of acute and late side-effects resulting from SBRT assessed using the Common Terminology Criteria for Adverse Events (CTCAE) and the Radiotherapy and Oncology Group Terminology Criteria for Adverse Events (CTCAE) and the RTOG (Radiotherapy Oncology Group) scoring criteria

Patient Reported Quality of Life assessed using the Euroqual (EQ) EQ-5D-5L questionnaire

Survival and median survival prior to alternative therapy administration

Correlation or regression analysis of characteristics (e.g. number of metastases)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.	NCT03644303	Prostate Cancer Metastasis Toxicity Due to... Circulating Tum...	SBRT + ADT	18 Years -	Royal Marsden NHS Foundation Trust
Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.	NCT03644303	Prostate Cancer Metastasis Toxicity Due to... Circulating Tum...	SBRT + ADT	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for sbrt + adt

Every month we try and update this database with for sbrt + adt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sbrt + adt

Every month we try and update this database with for sbrt + adt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sbrt + adt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.