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

NCT02131649 | Completed

• 1 other identifier: GAP02-01.1
• Study Type: interventional
• Target: 99
• Locations: 3 countries
• Sites: 10

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; PET; MRI; Fluorocholine; Radiotherapy; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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

  Within 2 weeks of 18F-FCH PET scan

Secondary Outcomes (1)

• Biochemical disease free survival at 3 years post-treatment

  3 years post-treatment

Study Arms (1)

18F-FCH PET/MRI Scan

EXPERIMENTAL

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

Device: 18F-FCH PET/MRI Scan

Interventions

18F-FCH PET/MRI Scan DEVICE

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.

18F-FCH PET/MRI Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (10)

St. Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Eastern Health

Melbourne, Victoria, 3128, Australia

Location

Lawson Health Research Institute, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

University of Toronto

Toronto, Ontario, M5G 2M9, Canada

Location

Universite Laval Quebec

Laval, Quebec, G1V 0A6, Canada

Location

Velindre Cancer Centre

Cardiff, South Glamorgan, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Glenn Bauman, MD

  London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 6, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

CA (3); GB (3); AU (4)