- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02131649
PET/MRI for Men Being Considered for Radiotherapy for Suspected Prostate Cancer Recurrence Post-Prostatectomy (PROPS)
PROPS (PET/MRI Pre-Radiotherapy for Post-Prostatectomy Salvage)
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
New South Wales
-
Sydney, New South Wales, Australië, 2010
- St. Vincent's Hospital
-
-
Victoria
-
Melbourne, Victoria, Australië, 3002
- Peter MacCallum Cancer Centre
-
Melbourne, Victoria, Australië, 3084
- Austin Hospital
-
Melbourne, Victoria, Australië, 3128
- Eastern Health
-
-
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Lawson Health Research Institute, London Health Sciences Centre
-
Toronto, Ontario, Canada, M5G 2M9
- University of Toronto
-
-
Quebec
-
Laval, Quebec, Canada, G1V 0A6
- Université Laval Quebec
-
-
-
-
-
London, Verenigd Koninkrijk, SW3 6JJ
- Royal Marsden Hospital
-
London, Verenigd Koninkrijk, NW1 2BU
- University College London Hospital
-
-
South Glamorgan
-
Cardiff, South Glamorgan, Verenigd Koninkrijk
- Velindre Cancer Centre
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
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
Tijdsspanne: Within 2 weeks of 18F-FCH PET scan
|
Within 2 weeks of 18F-FCH PET scan
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Biochemical disease free survival at 3 years post-treatment
Tijdsspanne: 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.
|
3 years post-treatment
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Glenn Bauman, MD, London Regional Cancer Program
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GAP02-01.1
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Prostaatkanker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
-
University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
-
BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
-
Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
-
Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)WervingAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
-
University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
Klinische onderzoeken op 18F-FCH PET/MRI Scan
-
Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)VoltooidHersenmetastasenVerenigde Staten
-
University Health Network, TorontoProstate Cancer CanadaVoltooid
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR)Voltooid
-
Sir Mortimer B. Davis - Jewish General HospitalVoltooidProstaatkankerCanada
-
University Health Network, TorontoVoltooidHyperparathyreoïdie, primair | Positron-emissietomografie | 18F-fluorocholineCanada
-
Lawson Health Research InstituteOICRBeëindigdProstaatkankerCanada
-
Glenn BaumanUnited States Department of Defense; Western University, Canada; Centre for Probe...WervingProstaatkanker | Prostaat Adenocarcinoom | Prostaat NeoplasmaCanada
-
University Health Network, TorontoWervingPost prostatectomieCanada
-
Sir Mortimer B. Davis - Jewish General HospitalVoltooid