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Prostate SABR With Intra-Prostatic SABR Boost

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Pelvic SABR with intra-prostatic SABR
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
  • Willing to give informed consent to participate in this clinical trial

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate MRI
  • 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

  • King Saud University Medical CityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs

Outcomes

Primary Outcome Measures

Acute Toxicity
To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Secondary Outcome Measures

Full Information

First Posted
December 26, 2019
Last Updated
December 27, 2019
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04212715
Brief Title
Prostate SABR With Intra-Prostatic SABR Boost
Official Title
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.

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
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs
Intervention Type
Radiation
Intervention Name(s)
Pelvic SABR with intra-prostatic SABR
Intervention Description
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Primary Outcome Measure Information:
Title
Acute Toxicity
Description
To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time Frame
3 month after accrual is completed

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 High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL Willing to give informed consent to participate in this clinical trial Exclusion Criteria: Prior pelvic radiotherapy Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Contraindication to prostate MRI 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasir Alayed, MD
Phone
+966114671546
Email
yalayed@ksu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasir Alayed, MD
Organizational Affiliation
King Saud University Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Saud University Medical City
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasir Alayed, MD
Phone
+966114671546
Email
yalayed@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Yasir Alayed, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prostate SABR With Intra-Prostatic SABR Boost

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