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PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy (PROPS)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
18F-FCH PET/MRI Scan
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, PET, MRI, Fluorocholine, Radiotherapy, Prostatectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Male, aged 18 years or older.
  • Confirmation of prostate cancer on prostatectomy pathology report.
  • No lymph node involvement (N0 or Nx) reported on prostatectomy pathology report.
  • Documented PSA rise measured on 3 occasions.
  • PSA ≥ 0.2 ng/ml at enrolment.
  • At least one adverse feature: Current PSA > or equal to 1.0, Initial Gleason Grade > or equal to 8, Positive surgical margin, pT3b (seminal vesicle involvement), or PSA doubling time < 10 months.
  • Bone scan and CT scan within 12 weeks of enrolment negative or equivocal for metastatic disease.
  • Suitable candidate for radiotherapy and not yet had any salvage treatment post-prostatectomy.

Exclusion Criteria:

  • Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components.
  • Proven metastatic disease.
  • Patients who refuse salvage prostate bed radiotherapy.
  • Patients who refuse to join the trial or are unable to consent.
  • Patients not being considered for further therapy.
  • Patients who cannot lie still for at least 30 minutes or comply with imaging.
  • Unequivocal evidence of disease outside the prostate bed on conventional imaging
  • Allergy to MRI contrast agent (exclusion for MRI component only) or PET tracer to be used as part of the imaging
  • Sickle cell disease or other anemias
  • Insufficient renal function (eGFR < 30 mL/min/1.73 m2)
  • Residual bladder volume > 150 cc (determined by post-void ultrasound)
  • Hip prosthesis, vascular grafting or other conditions affecting imaging or delivery of therapeutic radiation
  • Contraindication to MRI, including but not restricted to: pacemaker or other electronic implants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, Shrapnel, tattoos, non-removable body piercings (relative contraindications)
  • Hormone Androgen deprivation therapy of any type within 6 months prior to enrollment

Sites / Locations

  • St. Vincent's Hospital
  • Peter MacCallum Cancer Centre
  • Austin Hospital
  • Eastern Health
  • Lawson Health Research Institute, London Health Sciences Centre
  • University of Toronto
  • Universite Laval Quebec
  • Velindre Cancer Centre
  • University College London Hospital
  • Royal Marsden Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FCH PET/MRI Scan

Arm Description

Patients will undergo an injection of 18F-fluoromethyl-choline at 3.6 MBq/kg followed by whole body PET/CT imaging. Patients will also undergo a whole body MRI including T2 weighted, Diffusion weighted and Gadolinium Contrast Enhanced sequences. Patients with suspicion for recurrence may undergo biopsy if lesions identified on PET/CT or MRI are accessible for biopsy

Outcomes

Primary Outcome Measures

Proportion of men with negative or equivocal conventional restaging imaging (bone scan + CT scan of abdomen and pelvis) with uptake identified outside of the prostate bed on 18F-FCH PET

Secondary Outcome Measures

Biochemical disease free survival at 3 years post-treatment
Whether biochemical (PSA) control rates 3 years post-treatment are improved for participants with 18F-FCH PET imaging that was negative or demonstrated uptake confined to the prostate bed and received salvage pelvic radiotherapy compared to published results for men with adverse features.

Full Information

First Posted
May 1, 2014
Last Updated
April 4, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02131649
Brief Title
PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy
Acronym
PROPS
Official Title
PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2021 (Actual)

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
No

5. Study Description

Brief Summary
The PROPS trial is for men being considered for radiotherapy due to the suspicion that their prostate cancer has recurred following the surgical removal of their prostate (prostatectomy). This suspicion is based on rises seen on Prostate Specific Antigen (PSA) blood tests. Only men who demonstrate the absence of disease on standard imaging scans (Computed Tomography (CT) and bone scans) will be invited to participate. This study will be assessing if the imaging probe 18-F Fluorocholine (18F-FCH) used during Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) scans, can better predict who will benefit from radiotherapy by identifying the source of cancer recurrence. This will be determined by measuring the number of men who have disease identified outside of the prostate bed (the small pocket or depression where the prostate used to be) on their 18F-FCH PET scan. Since F-18-FCH has been shown to be more sensitive in detecting prostate cancer that may have spread into lymph nodes or bone, it may potentially identify areas of prostate cancer spread not seen with standard imaging.
Detailed Description
The study will be a non-randomized, prospective study of men with suspected local recurrence of prostate cancer post-prostatectomy with negative conventional re-staging studies (bone scan and CT of the abdomen and pelvis; MRI of the pelvis as part of re-staging is allowed where it is the institutional standard of care). The clinician will develop an initial treatment plan based on conventional re-staging information. Patients enrolled onto trial will undergo hybrid PET/MR imaging using 18F-FCH (sites without access to a hybrid PET/MR scanner will conduct a 18F-FCH PET/CT in addition to a full body MRI). A consensus staging report based on local and centralized review of the 18F-FCH PET imaging will be provided to the attending clinician, who will document a second treatment plan based on this additional information. The treatment plan to be implemented (initial or second) will be left to clinician discretion, but will be documented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, PET, MRI, Fluorocholine, Radiotherapy, Prostatectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FCH PET/MRI Scan
Arm Type
Experimental
Arm Description
Patients will undergo an injection of 18F-fluoromethyl-choline at 3.6 MBq/kg followed by whole body PET/CT imaging. Patients will also undergo a whole body MRI including T2 weighted, Diffusion weighted and Gadolinium Contrast Enhanced sequences. Patients with suspicion for recurrence may undergo biopsy if lesions identified on PET/CT or MRI are accessible for biopsy
Intervention Type
Device
Intervention Name(s)
18F-FCH PET/MRI Scan
Intervention Description
Patients will first undergo screening to ensure eligibility. If eligible, they will undergo a PET/MRI scan using 18F-FCH as the radiolabeled tracer. If prostate cancer is detected outside the prostate, patients may undergo a biopsy or follow-up 18F-FCH PET/MRI to confirm the results.
Primary Outcome Measure Information:
Title
Proportion of men with negative or equivocal conventional restaging imaging (bone scan + CT scan of abdomen and pelvis) with uptake identified outside of the prostate bed on 18F-FCH PET
Time Frame
Within 2 weeks of 18F-FCH PET scan
Secondary Outcome Measure Information:
Title
Biochemical disease free survival at 3 years post-treatment
Description
Whether biochemical (PSA) control rates 3 years post-treatment are improved for participants with 18F-FCH PET imaging that was negative or demonstrated uptake confined to the prostate bed and received salvage pelvic radiotherapy compared to published results for men with adverse features.
Time Frame
3 years post-treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male, aged 18 years or older. Confirmation of prostate cancer on prostatectomy pathology report. No lymph node involvement (N0 or Nx) reported on prostatectomy pathology report. Documented PSA rise measured on 3 occasions. PSA ≥ 0.2 ng/ml at enrolment. At least one adverse feature: Current PSA > or equal to 1.0, Initial Gleason Grade > or equal to 8, Positive surgical margin, pT3b (seminal vesicle involvement), or PSA doubling time < 10 months. Bone scan and CT scan within 12 weeks of enrolment negative or equivocal for metastatic disease. Suitable candidate for radiotherapy and not yet had any salvage treatment post-prostatectomy. Exclusion Criteria: Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components. Proven metastatic disease. Patients who refuse salvage prostate bed radiotherapy. Patients who refuse to join the trial or are unable to consent. Patients not being considered for further therapy. Patients who cannot lie still for at least 30 minutes or comply with imaging. Unequivocal evidence of disease outside the prostate bed on conventional imaging Allergy to MRI contrast agent (exclusion for MRI component only) or PET tracer to be used as part of the imaging Sickle cell disease or other anemias Insufficient renal function (eGFR < 30 mL/min/1.73 m2) Residual bladder volume > 150 cc (determined by post-void ultrasound) Hip prosthesis, vascular grafting or other conditions affecting imaging or delivery of therapeutic radiation Contraindication to MRI, including but not restricted to: pacemaker or other electronic implants, known metal in the orbit, MR incompatible surgical or cerebral aneurysm clips, Shrapnel, tattoos, non-removable body piercings (relative contraindications) Hormone Androgen deprivation therapy of any type within 6 months prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Bauman, MD
Organizational Affiliation
London Regional Cancer Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Eastern Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Lawson Health Research Institute, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Universite Laval Quebec
City
Laval
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
South Glamorgan
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy

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