Single Fractions SBRT for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04004312|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : November 2, 2020
It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment.
Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Stereotactic Body Radiation Therapy (SBRT)||Not Applicable|
There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home.
The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment.
A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study|
|Actual Study Start Date :||November 7, 2018|
|Estimated Primary Completion Date :||September 15, 2021|
|Estimated Study Completion Date :||December 20, 2024|
Experimental: Single Fraction SBRT in the treatment of prostate cancer
Prior to treatment, a hydrogel spacer will be inserted between the recutm and prostate. A urinary catheter will also be inserted in the bladder. A single dose of 19Gy will be delivered with an IMRT technique. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
Other Name: Space OAR Gel
- Small bowel or rectal irritation, [ Time Frame: 3 months ]To assess acute gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;
- Bladder complications [ Time Frame: 3 months ]Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;
- To assess late GI and GU toxicity [ Time Frame: 3 years ]gastro-intestinal (GI) toxicity such as abdominal cramping, diarrhea, rectal urgency, proctitis, or hematochezia;and GU toxicity such as Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;
- PSA control [ Time Frame: 5 years ]To assess the rate of biochemical control
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004312
|Contact: Marianna Perna||514-934-1934 ext email@example.com|
|Contact: Tatiana Carvalho||514-934-1934 ext firstname.lastname@example.org|
|McGill University Health Centre-Cedars Cancer Centre||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Marianna Perna 514-934-1934 ext 43191 email@example.com|
|Contact: Tatiana Carvalho 514-934-1934 ext 43698 firstname.lastname@example.org|
|Principal Investigator: Fabio Cury, MD|
|Sub-Investigator: Luis Souhami, MD|
|Sub-Investigator: Marie Duclos, MD|
|Sub-Investigator: Sergio Faria, MD|
|Principal Investigator:||Fabio Cury, MD||McGill University Health Centre- Cedars Cancer Centre|