Prostate Cancer Clinical Trial
Official title:
TRAP - Targeted Radiotherapy in Androgen-suppressed Prostate Cancer Patients.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |