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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02131649




Registration number
NCT02131649
Ethics application status
Date submitted
1/05/2014
Date registered
6/05/2014
Date last updated
5/04/2022

Titles & IDs
Public title
PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy
Scientific title
PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)
Secondary ID [1] 0 0
GAP02-01.1
Universal Trial Number (UTN)
Trial acronym
PROPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - 18F-FCH PET/MRI Scan

Experimental: 18F-FCH PET/MRI Scan - 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


Treatment: Devices: 18F-FCH PET/MRI Scan
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Within 2 weeks of 18F-FCH PET scan
Secondary outcome [1] 0 0
Biochemical disease free survival at 3 years post-treatment
Timepoint [1] 0 0
3 years post-treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2021
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Austin Hospital - Melbourne
Recruitment hospital [4] 0 0
Eastern Health - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
United Kingdom
State/province [3] 0 0
South Glamorgan
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Lawson Health Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02131649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glenn Bauman, MD
Address 0 0
London Regional Cancer Program
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02131649