search
Back to results

PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER) (ARGOS/CLIMBER)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intermediate Risk Patients
High Risk or Very High-Risk Patients
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring High intermediate risk prostate cancer, High-risk prostate cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 18 years of age
  • Histologically confirmed carcinoma of the prostate
  • High-intermediate risk or high risk as defined by NCCN criteria:
  • High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or >50% biopsy core involvement
  • High-risk: one of T3a, Gleason GG 4 or 5, or PSA >20 ng/ml
  • Very-high risk: one of primary Gleason Pattern 5, >4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature
  • Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete EPIC questionnaires

Exclusion Criteria:

  • Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted
  • Men with clinical T4 disease are excluded
  • Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.)
  • Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy
  • Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?)
  • Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations

Sites / Locations

  • London Health Sciences CentreRecruiting
  • Sunnybrook Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Men with high intermediate to very high risk protstate cancer

Arm Description

Outcomes

Primary Outcome Measures

6-month Toxicity
6-month gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
6-week Toxicity
6-week gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

Secondary Outcome Measures

Quality of Life
Quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires.
Disease Free Survival
Five-year disease-free survival (DFS) as a composite of biochemical control, patient death or development of clinical metastases or institution of salvage ADT.

Full Information

First Posted
January 12, 2022
Last Updated
March 7, 2023
Sponsor
Lawson Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05269550
Brief Title
PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)
Acronym
ARGOS/CLIMBER
Official Title
PSMA MRI Guided Prostate SBRT(ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

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

5. Study Description

Brief Summary
This study is a prospective Phase I/II protocol enrolling men with either high intermediate-risk or high-risk or very high-risk prostate cancer. All men will have PSMA Targeted PET (using the PSMA targeting ligand PSMA 1007) and multiparametric magnetic resonance imaging (mpMRI) for delineation of intra-prostatic foci of cancer and any involved regional lymph nodes based on high SUV uptake on PET or mpMRI (T2W, DWI/ADC, DCE) appearance suspicious for cancer. Tumour delineation will be performed by fusing the PSMA PET and mpMRI with planning CT simulation images. Fiducial marker implantation for treatment guidance will be mandatory but use of other organs at risk protection strategies (i.e. GU Loc, Space-OAR) will be allowed but not mandatory. Patients will be treated with image-guided SBRT using the fiducial markers for intra-fraction motion management. Dose escalation to imaging defined targets (intra-prostatic and involved nodes on PSMA PET + MRI) will be accomplished through a simultaneous boost technique. Maintaining dose to organs at risk will take precedence over boost dose targets (targeted maximum dose of 50Gy/5 fractions to imaging defined prostatic lesion; 35Gy/5 fractions to imaging defined involved nodes).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
High intermediate risk prostate cancer, High-risk 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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Men with high intermediate to very high risk protstate cancer
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
High Intermediate Risk Patients
Intervention Description
Patients will receive 35Gy/5 fractions to the whole prostate (25 Gy to proximal Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Six months of androgen deprivation therapy will commence with the start of radiotherapy (concurrent plus adjuvant)
Intervention Type
Radiation
Intervention Name(s)
High Risk or Very High-Risk Patients
Intervention Description
Patients will receive 35Gy/5 fractions to the whole prostate (25Gy to whole Seminal Vesicles) with a simultaneous boost to PET/MRI defined intra-prostatic foci to a target maximum dose of 50Gy/5 fractions. Pelvic lymph nodes will receive 25Gy/5 fractions synchronous with prostate treatment with a simultaneous boost to imaging involved nodes to a maximum of 35Gy/5 fractions. Eighteen months of androgen deprivation therapy will commence with the start of radiotherapy (concurrent plus adjuvant)
Primary Outcome Measure Information:
Title
6-month Toxicity
Description
6-month gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time Frame
6-months
Title
6-week Toxicity
Description
6-week gastrointestinal (GI) and genitourinary (GU) toxicity using the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of life measured by the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaires.
Time Frame
5 years
Title
Disease Free Survival
Description
Five-year disease-free survival (DFS) as a composite of biochemical control, patient death or development of clinical metastases or institution of salvage ADT.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years of age Histologically confirmed carcinoma of the prostate High-intermediate risk or high risk as defined by NCCN criteria: High intermediate: 2 or 4 intermediate risk factors (T2B-T2C, Gleason GG 2 or 3, PSA 10-20) or GG 3 or intermediate risk with equal or >50% biopsy core involvement High-risk: one of T3a, Gleason GG 4 or 5, or PSA >20 ng/ml Very-high risk: one of primary Gleason Pattern 5, >4 cores Grade Group 4 or 5, clinical T3b, or more than 1 high-risk feature Conventional imaging (bone scan and abdominal pelvic computed tomography) negative for extra-pelvic nodal, skeletal or visceral metastases Willing to give informed consent to participate in this clinical trial Able and willing to complete EPIC questionnaires Exclusion Criteria: Prior prostate cancer treatment (apart from prior 5-alpha reductase inhibitor treatment); androgen deprivation therapy prior to enrollment or treatment planning not permitted Men with clinical T4 disease are excluded Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease Contraindication to prostate MRI (i.e. non0compatible stent, pacemaker, prosthesis, etc.) Contraindication to use of PSMA PET agent PSMA 1007 due to intolerance or allergy Anticoagulation medication (if unsafe to discontinue for gold seed insertion) Diagnosis of bleeding diathesis Poor baseline urinary function defined as a score of 5 ("big problem") on question 5 of the EPIC 26 (Overall, how big a problem has your urinary function been for you during the last 4 weeks?) Definitive extra-pelvic nodal or distant metastatic disease on conventional staging investigations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glenn Bauman, MD
Phone
519-685-8650
Email
Glenn.Bauman@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Mendez, MD
Phone
519-685-8650
Email
Lucas.Mendez@lhsc.on.ca
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Bauman, MD
Phone
519-685-8500
Email
Glenn.Bauman@lhsc.on.ca
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Loblaw, MD
Email
Andrew.Loblaw@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PSMA MRI Guided Prostate SBRT (ARGOS)/Comprehensive, Longitudinal Evaluation of Imaging Biomarkers Post Radiotherapy (CLIMBER)

We'll reach out to this number within 24 hrs