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Single Fractions SBRT for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004312
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Fabio Cury, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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;

  2. Bladder complications [ Time Frame: 3 months ]
    Bladder complications including urinary frequency/urgency, dysuria, hematuria, urinary tract infection, and incontinence;


Secondary Outcome Measures :
  1. 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;

  2. PSA control [ Time Frame: 5 years ]
    To assess the rate of biochemical control



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride)

Recent PSA under 15 ng/dL (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride)

International Prostate Symptom Score <16 Prostate gland volume< 80cc

Zubrod Performance Status 0-1 within 60 days prior to registration

Age >: 18

Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance.

Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).

Evidence of distant metastases

Regional lymph node involvement

Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy)

Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride.

Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride.

Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

Transmural myocardial infarction within the last 6 months

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.)

Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.


Information from the National Library of Medicine

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


Contacts
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Contact: Marianna Perna 514-934-1934 ext 43191 marianna.perna@muhc.mcgill.ca
Contact: Tatiana Carvalho 514-934-1934 ext 43698 tatiana.carvalho@muhc.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Marianna Perna    514-934-1934 ext 43191    marianna.perna@muhc.mcgill.ca   
Contact: Tatiana Carvalho    514-934-1934 ext 43698    tatiana.carvalho@muhc.mcgill.ca   
Principal Investigator: Fabio Cury, MD         
Sub-Investigator: Luis Souhami, MD         
Sub-Investigator: Marie Duclos, MD         
Sub-Investigator: Sergio Faria, MD         
Sponsors and Collaborators
Fabio Cury
Boston Scientific Corporation
Investigators
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Principal Investigator: Fabio Cury, MD McGill University Health Centre- Cedars Cancer Centre
Publications:

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Responsible Party: Fabio Cury, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04004312    
Other Study ID Numbers: 2019-4650
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fabio Cury, McGill University Health Centre/Research Institute of the McGill University Health Centre:
single fraction
SBRT
Space OAR Gel
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases