Advertisement

Topics

A Randomised Controlled Phase II Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy

2016-12-01 16:08:22 | BioPortfolio

Summary

A two-arm randomised controlled trial in patients receiving post-prostatectomy radiotherapy in the adjuvant or salvage setting, with patients randomised to receive daily ProSpare (obturator) guided IMRT or Centre standard (non-obturator) guided IMRT.

Description

Surgery to remove the prostate gland is one of the ways of treating prostate cancer. Some patients receive radiotherapy after surgery if the cancer may not have been completely removed. Radiotherapy to the area where the prostate was can cause side effects, which can cause bowel and bladder symptoms as well as reducing sexual function.

Radiotherapy alone is also a standard treatment for prostate cancer. At the Royal Marsden Hospital and Institute of Cancer Research we have designed and patented a device called ProSpare to improve the accuracy of radiotherapy. The device has already been developed and tested in over 80 patients having prostate radiotherapy and was well tolerated. Treatment accuracy was improved and the radiation dose to the rectum was reduced. Patients have given very valuable feedback and comments about ProSpare's design and use, which we have incorporated in the final design. We now want to test ProSpare in a multi-centre randomised controlled trial. We aim to find out whether ProSpare will reduce the side effects reported by patients having radiotherapy after prostatectomy.

The ProSpare device is inserted by the patient into the rectum for each daily radiotherapy treatment. The disposable device stays in place for about 15 minutes each day. The curve in the device is designed to follow the shape of the rectum and it stays in the correct place by securely locating in the anal sphincter. ProSpare contains small "markers" - steel ball bearings - which can be "seen" on the standard scans taken before a radiotherapy treatment. Treatment is adjusted before each daily treatment to account for patient movement and radiotherapy set-up variation. As a result, treatment is more accurate than using the standard methods of radiotherapy localisation. This means we can reduce the radiotherapy "safety margins", which are placed around the prostate bed. The dose to the rectum and bladder as well as the structures that are associated with erectile function will be reduced. This may lead to an improvement in the side effects caused by radiotherapy.

Other ways to identify the treatment target area for such image guided radiotherapy (IGRT) include the insertion of fiducial markers - usually in the form of gold seeds into the prostate or prostate bed. This has become standard practice in some radiotherapy centres for prostate radiotherapy but is technically complex for prostate bed radiotherapy and not routinely used. ProSpare has the additional advantage of being non-invasive and without the risk of infection associated with fiducial insertion.

Patients will be randomly selected to either have standard treatment or use ProSpare daily with adjusted set-up margins. During and after treatment, patients will be asked questions and given questionnaires to complete, asking about bowel, urinary and sexual function. We will look at the results in each group and see if treatment with ProSpare has a benefit in improving the side effects from radiotherapy. If a benefit is seen, then our aim would be for ProSpare guided radiotherapy to become part of the standard treatment for prostate bed radiotherapy nationally and internationally.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer

Intervention

Rectal obturator

Location

The Royal Marsden NHS Foundation Trust
Sutton
Surrey
United Kingdom
SM2 5PT

Status

Recruiting

Source

Royal Marsden NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:22-0500

Clinical Trials [452 Associated Clinical Trials listed on BioPortfolio]

Comparison of Obturator Nerve Blockade and Neuromuscular Blockade

Patients diagnosed with posterolateral bladder tumors will be invited to participate in the study. Subjects will be randomized to receive an ultrasound-guided obturator block or a neuromus...

Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Rectal Cancer Staging Using Whole Body MR-PET

The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and ...

Preoperative Chemoradiotheray for Rectal Cancer

Hypothesis - Pre operative radio-chemotherapy might be not mandatory to improve local recurrent rate and survival rate in the mid-lower rectal cancer patients with T3N0 clinical s...

Palliative Short-Course Radiotherapy in Rectal Cancer

Radiotherapy (RT) is a potentially effective method in the treatment of symptoms of rectal carcinomas. Nevertheless, almost all the evidences about palliative RT in rectal cancer have been...

PubMed Articles [14454 Associated PubMed Articles listed on BioPortfolio]

Rectal Cancer in Patients Under 50 Years of Age.

General population screening for colorectal cancer starts at 50, and incidence rates of rectal cancer in patients over 50 years old are decreasing. However, incidence of rectal cancer under age 50 is...

Feasibility and Efficacy of Presurgical Exercise in Survivors of Rectal Cancer Scheduled to Receive Curative Resection.

Localized rectal carcinoma is invasive, with surgical resection the standard treatment. The aim of this study was to determine the feasibility of a supervised presurgical exercise intervention in pati...

A Retrospective Cohort Study of the Cumulative Survival Rate of Obturator Prostheses for Marsupialization.

After marsupialization of benign tumors and jawbone cysts, insertion of an obturator prosthesis maintains the surgical opening and improves hygiene. To date, there have been no reports clarifying the ...

Pathologic Outcomes of Laparoscopic vs Open Mesorectal Excision for Rectal Cancer: A Systematic Review and Meta-analysis.

Rectal resection with mesorectal excision is the mainstay treatment for rectal cancer.

Expression of SLP-2 gene and CCBE1 are associated with prognosis of rectal cancer.

This study aims to investigate the clinical significance of SLP-2 gene for patients with rectal cancer. To analyze the effect of CCBE1 (Collagen and calcium-binding EGF domain-containing protein 1) on...

Medical and Biotech [MESH] Definitions

A pelvic hernia through the obturator foramen, a large aperture in the hip bone normally covered by a membrane. Obturator hernia can lead to intestinal incarceration and INTESTINAL OBSTRUCTION.

Tumors or cancer of the RECTUM.

A nerve originating in the lumbar spinal cord (L2 to L4) and traveling through the lumbar plexus to the lower extremity. The obturator nerve provides motor innervation to the adductor muscles of the thigh and cutaneous sensory innervation of the inner thigh.

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A compound tubular gland, located around the eyes and nasal passages in marine animals and birds, the physiology of which figures in water-electrolyte balance. The Pekin duck serves as a common research animal in salt gland studies. A rectal gland or rectal salt gland in the dogfish shark is attached at the junction of the intestine and cloaca and aids the kidneys in removing excess salts from the blood. (Storer, Usinger, Stebbins & Nybakken: General Zoology, 6th ed, p658)

More From BioPortfolio on "A Randomised Controlled Phase II Trial Assessing Post-Operative Use of ProSpare, a Rectal Obturator in Prostate Cancer Radiotherapy"

Quick Search
Advertisement
 

Relevant Topic

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...


Searches Linking to this Trial