Prostate Cancer Clinical Trial
— PRISMOfficial title:
Prostate Radiotherapy Integrated With Simultaneous MRI (The PRISM Study)
NCT number | NCT03658525 |
Other study ID # | CCR4888 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 7, 2018 |
Est. completion date | August 2023 |
Currently radiotherapy for prostate cancer is directed using scans or X-Rays, which ensures
the radiotherapy treatment 'hits the target' and avoids the healthy tissues around the
prostate. There are two current methods of radiotherapy image guidance- either placing small
gold seeds into the prostate and taking XRays or doing a small CT scan of the prostate region
each day. Neither of these methods are perfect and have drawbacks and inaccuracies.
The best way to see the prostate is with an MRI scan - this shows the edge of the prostate
much more clearly and can even show the area of most aggressive cancer within the prostate.
Shortly the investigators will have the ability to use a new machine - an MR-Linac - which
combines an MR scanner and a radiotherapy machine.
As well as giving the investigators a clearer picture, and enabling the investigators to keep
watching the prostate while the participant has their treatment (not currently possible with
standard machines) this new machine will also allow the investigators to change the
radiotherapy plan if they can see that the internal anatomy has shifted day to day. Currently
the investigators have to give the same radiotherapy plan each day, which means the
investigators have to treat a 'safety margin' around to prostate to allow for these day to
day anatomy changes (e.g. rectal filling).
The aim of this study is to assess the technical feasibility of delivering radical
radiotherapy for prostate cancer using the MR-Linac, including the feasibility of changing
the radiotherapy plan on a daily basis to mirror internal anatomy changes. The investigators
will recruit 30 patients with localised prostate cancer who need radiotherapy. The team will
deliver the same dose in the same number of days i.e. the same as standard radiotherapy. Side
effects will also be assessed by physicians and using patient questionnaires.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2023 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: All of the following criteria should be met for study entry. - Histologically confirmed adenocarcinoma prostate- grade group 3 or less (Gleason 4+3=7 or less). - Staging T2-T3a,N0M0 (MRI or DRE staging allowed). - PSA<25. - 6 months short course androgen deprivation therapy allowed, not mandated. - Maximum prostate volume 70cc. - IPSS <12 at baseline. - WHO performance status 0 or 1. - Written informed consent. Exclusion Criteria: If one of the following criteria are met, the patient is not eligible for the study - Other invasive malignancy within the last two years- excluding basal cell carcinoma and squamous cell carcinoma of the skin. - Patients who, in the opinion of the Local PI, require long course (> 6 months) ADT. - Contraindications to MRI.Including pacemaker, implanted devices, any non-MR compatible metallic implants.Severe claustrophobia. - Contraindications to gold fiducial marker implantation.Clotting disorders, very high risk of bleeding.Clinically unacceptable risk of temporarily stopping anticoagulation or antiplatelet medications. - Contraindications to prostate radiotherapy,Previous pelvic radiotherapy.Clinically significant inflammatory bowel disease. - Bilateral or single hip replacements. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden - Surrey | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients in whom the imaging and treatment on the MR Linac (i.e. total time on the treatment couch) can be completed within 1 hour on 90% of fractions as assessed by the radiotherapy timing sheet. | The radiotherapy timing sheet will be used to record the length of time for patients to have their MR guided adaptive radiotherapy for each fraction. This information will then inform if treatment can be given in a clinically feasible time frame. | 2 YEARS |
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 | |
Active, not recruiting |
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 |