Back to results5 Fractions of Pelvic SABR With Intra Prostatic SABR (5STAR)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic SABR with intra-prostatic SABR
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- High- tier intermediate risk defined as:
PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )
• High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Exclusion Criteria:
- Prior pelvic radiotherapy
- Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Contraindication to prostate MRI
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
- Previous TURP
- Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
- Significant medical co-morbidity rendering patient unsuitable for general anesthetic
- No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Pelvic SABR with intra-prostatic SABR
Outcomes
Primary Outcome Measures
To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02911636
Brief Title
5 Fractions of Pelvic SABR With Intra Prostatic SABR
Acronym
5STAR
Official Title
5 Fractions of Pelvic SABR With Intra Prostatic SABR
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Loblaw
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT
Detailed Description
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Pelvic SABR with intra-prostatic SABR
Intervention Type
Radiation
Intervention Name(s)
Pelvic SABR with intra-prostatic SABR
Intervention Description
described elsewhere
Primary Outcome Measure Information:
Title
To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
Time Frame
3 months after accrual target is reached
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed prostate adenocarcinoma (centrally reviewed)
High- tier intermediate risk defined as:
PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )
• High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA > 20 ng/mL
Willing to give informed consent to participate in this clinical trial
Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Exclusion Criteria:
Prior pelvic radiotherapy
Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
Contraindication to prostate MRI
Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
Diagnosis of bleeding diathesis
Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
Previous TURP
Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
Significant medical co-morbidity rendering patient unsuitable for general anesthetic
No evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
5 Fractions of Pelvic SABR With Intra Prostatic SABR
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