- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02911636
5 Fractions of Pelvic SABR With Intra Prostatic SABR (5STAR)
November 23, 2020 updated by: Andrew Loblaw
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Pelvic SABR with intra-prostatic SABR
|
described elsewhere
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months after accrual target is reached
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
September 1, 2017
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
September 14, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 23, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 360-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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