Prostate Cancer Clinical Trial
— 2SMARTOfficial title:
Two Stereotactic MRI-Guided Ablative Adaptive Radiotherapy Treatments for Localized Prostate Cancer (2SMART)
Verified date | June 2022 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This single arm, prospective study will determine the prostate-specific quality of life (QOL) of patients undergoing undergoing a 2 fraction MRI-guided stereotactic ablative body radiation (SABR) protocol. We propose prescribing a prostate dose of 26 Gy in 2 fractions and a dose of up to 32 Gy to the dominant intraprostatic lesion (DIL) in 2 fractions over one week.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | April 23, 2024 |
Est. primary completion date | January 23, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Informed consent obtained 2. Men >18 years 3. Histologically confirmed prostate adenocarcinoma (centrally reviewed) 4. Favorable risk prostate cancer, defined as clinical stage T1-2c, Gleason Sum less than or equal to 7, and PSA less than or equal to 20 ng/mL (patients can have only one of T2c, Gleason Sum 7 and PSA 10-20 ng/ml) Exclusion Criteria: 1. Androgen deprivation therapy (LHRH-agonists or antiandrogens) > 6 mo 2. Prior pelvic radiotherapy 3. Anticoagulation medication (if unsafe to discontinue for gold seed insertion) 4. Diagnosis of bleeding diathesis 5. Large prostate (>90cm3) on imaging 6. Immunosuppressive medications 7. Inflammatory bowel disease 8. Presence of a hip prosthesis 9. Contraindications to having MRI |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QOL | To determine the prostate-specific quality of life (QOL) using the Expanded Prostate Cancer Index Composite (EPIC) | 5 years | |
Secondary | Acute Toxicity | Incidence of acute (=3 months) complications of interest using Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4) | 3months | |
Secondary | Late Toxicity | Incidence of late (=6 months) complications of interest (CTCAE v4) | 5 Years | |
Secondary | PSA | Proportion of patients with 4 year PSA value < 0.4 ng/ml | 5 years | |
Secondary | Biochemical Recurrance | 5 year biochemical failure rates using the Phoenix definition (nadir PSA + 2 ng/mL) | 5 years | |
Secondary | Salvage Therapy | Rate of salvage therapy (ADT, surgery or brachytherapy) | 5 years | |
Secondary | Health Utilities | Health utilities using the EuroQol-5Dimensions (EQ-5D) questionnaire for mobility, usual activities, anxiety/depression, self-care and pain/discomfort. | 5 year | |
Secondary | Health Utilities | Health utilities using the Patient Oriented Prostate Ultility Scale (PORPUS-U) (0=best quality of life to 1=worst quality of life) | 5 year |
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