Status:
ACTIVE_NOT_RECRUITING
Tumor TARGET Prostate Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Prostate cancer is common in males and may develop over the course of an individual's life. This cancer is often discovered at the time of routine physical examinations and/or blood work or on rectal ...
Detailed Description
This is a prospective two arm phase 2 trial investigating the technical and clinical performance of tumor-targeted (rather than prostate targeted) radiotherapy. Cohort 1 (Control group): This group c...
Eligibility Criteria
Inclusion
- Inclusion Criteria \[applicable to both Cohorts 1 (control) and Cohort 2 (Experimental) unless otherwise specified\]:
- Histological evidence of prostate adenocarcinoma.
- Discrete intra-prostatic tumor that can be confidently visualized on MRI prior to radiotherapy (\>5mm maximum diameter but \<33% of prostate volume, biopsy confirmed from initial diagnosis or interventional Biopsy) )
- At least 18 years old
- ECOG performance status 0 or 1 with \> 10-year life expectancy
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include standard care laboratory tests or imaging studies).
- Patients will be one of the following risk groups prior to therapy:
- Low-risk disease (Gleason 6 and PSA \<10 and T1) AND \>50% of biopsy cores involved with tumor
- Intermediate-risk disease (Gleason 7 or PSA 10-20 or T2)
- High-risk disease (Gleason \>8 or T3 or PSA \>20)
- Risk of LN involvement \<30% (Roach formula = 2/3PSA(\[G-6\]x10))
- Patients who received 78Gy RT to the prostate gland 3-4.5 years prior to enrollment (Cohort 1 only)
- Exclusion Criteria \[applicable to both Cohorts 1 (control) and Cohort 2(Experimental) unless otherwise specified\]:
- Previous history of radiation therapy to the prostate (Cohort 2)
- Diagnosis of another cancer not being skin cancer within the last 5 years (Cohort 2)
- Patients weighing \>136kgs (weight limit for the scanner tables)
- Patients with contraindications to MRI: this includes patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI determination. Exceptions will be allowed if deemed sage and appropriate by the MRI technologist.
- Severe claustrophobia
- Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased precluding biopsy
- Current hormonal therapy (Cohort 1) or initiated \>2 weeks prior to enrollment (Cohort 2)
- Radiological evidence of regional or distant metastases (Cohort 2)
- Other urinary or medical conditions deemed by the PI or associates to make the patient ineligible for MRI-guided prostate biopsy
- Contraindications to the endorectal coil, surgically absent rectum, severe hemorrhoids or previous colorectal surgery
- Contraindications to conscious sedation
- Latex allergy
- History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE (Cohort 2)
- Other medical conditions deemed by the PI to make patient ineligible for study intervention
Exclusion
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01802242
Start Date
October 1 2012
End Date
May 1 2025
Last Update
March 18 2024
Active Locations (1)
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1
University Health Network, The Princess Margaret
Toronto, Ontario, Canada, M5G 2M9