免费获得国外相关药品，最快 1 个工作日回馈药物信息
Single Fractions SBRT for Prostate Cancer
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 |
| 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 |
| 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
|
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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.
| 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 |
| 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 | |
| Principal Investigator: | Fabio Cury, MD | McGill University Health Centre- Cedars Cancer Centre |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 28, 2019 | ||||||||
| First Posted Date ICMJE | July 2, 2019 | ||||||||
| Last Update Posted Date | November 2, 2020 | ||||||||
| Actual Study Start Date ICMJE | November 7, 2018 | ||||||||
| Estimated Primary Completion Date | September 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Single Fractions SBRT for Prostate Cancer | ||||||||
| Official Title ICMJE | Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study | ||||||||
| 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 |
||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Prostate Cancer | ||||||||
| Intervention ICMJE | 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
|
||||||||
| Study Arms ICMJE | 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.
Intervention: Radiation: Stereotactic Body Radiation Therapy (SBRT)
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
12 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 20, 2024 | ||||||||
| Estimated Primary Completion Date | September 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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. |
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04004312 | ||||||||
| Other Study ID Numbers ICMJE | 2019-4650 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Fabio Cury, McGill University Health Centre/Research Institute of the McGill University Health Centre | ||||||||
| Study Sponsor ICMJE | Fabio Cury | ||||||||
| Collaborators ICMJE | Boston Scientific Corporation | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | McGill University Health Centre/Research Institute of the McGill University Health Centre | ||||||||
| Verification Date | October 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
