Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02131649