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Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

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ClinicalTrials.gov Identifier: NCT03160794
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

In the clinical scenario of recurrent prostate cancer (PCa) post local therapy, current standard studies (bone scan and computed tomography) commonly fail to identify the recurrent disease location. In this study the investigator aims to prospectively map recurrent disease with the unique combination of whole-body MR anatomical imaging combined with a new high-sensitivity and PCa-specific PET probe (PSMA-targeted: [18F]DCFPyL) to provide precise localization information to target disseminated tumor deposits in men presenting with rising PSA after prostatectomy and radiotherapy (maximal local therapies). Moreover, we will consequently treat all identified disease with image-guided stereotactic ablative radiotherapy (SABR), which has shown tantalizing results achieving excellent tumor eradication rates with minimal toxicities. This study is uniquely positioned to enable the discovery of new biomarkers and the correlation of prognostic tests (e.g. genomic signatures) from the initial prostatectomy specimen with the PET-MR/CT imaging results and curative-intent treatment outcomes.

The significance of the proposed work towards a measurable impact in PCa care is important to emphasize. The study team believes this novel curative-intent approach will transform lives, as opposed to therapies that transiently impact incurable disease stages. Herein, the focus is on patients at the earliest point of the disease spectrum of recurrent PCa after curative-intent treatments. Our hypothesis is that PSMA-targeted [18F]DCFPyL PET-MR/CT allows earlier detection and localization of defined metastatic targets in these patients, at a stage amenable to image-guided curative-intent therapy.


Condition or disease Intervention/treatment Phase
Post Prostatectomy Diagnostic Test: [18F]DCFPyL PET/MRI scan Radiation: Stereotactic Ablative Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: [18F] DCFPyL PET/MRI

[18F] DCFPyL PET/MRI scans for patients with recurrent disease after radical prostatectomy and adjuvant/salvage radiotherapy.

Lesions identified through [18F] DCFPyL PET/MRI will be treated with stereotactic ablative radiotherapy (SABR) or surgery.

Diagnostic Test: [18F]DCFPyL PET/MRI scan
PET/MRI imaging using the radiotracer, [18F]DCFPyL

Radiation: Stereotactic Ablative Radiotherapy
SABR as treatment for lesions identified using [18F]DCFPyL PET/MRI




Primary Outcome Measures :
  1. To determine if [18F]DCFPyL PET-MR/CT can identify early oligometastatic disease in patients with a rising PSA and negative staging (CS and BS) after standard-of-care maximal local therapies. [ Time Frame: 3 years ]
    Endpoint: Detection rates and performance metrics of [18F]DCFPyL PET-MR/CT in the post-prostatectomy plus adjuvant/salvage RT setting.

  2. To determine if treating PET-MR/CT identified lesions with curative-intent treatment (e.g. stereotactic body radiation therapy or surgery) associated with favorable preliminary measures of clinical performance. [ Time Frame: 3 Years ]
    • Proportion of patients achieving biochemical response: detectable PSA (<0.05ng/mL) in 2 consecutive measurements (at least 2 weeks apart) within 6 months of treatment); or > 50% PSA decline in 2 separate measurements at least 1 month apart within 6 months of treatment
    • Metabolic [18F]DCFPyL response rate after treatment
    • Treatment-related toxicities incidence as defined by CTCAE v4.0
    • Time to initiation of salvage ADT after treatment


Secondary Outcome Measures :
  1. Correlation between PSA kinetics and PET imaging parameters [ Time Frame: 6 months post SABR ]
    To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)

  2. Correlate between tissue biomarker and distant disease [ Time Frame: 3 years ]
    To explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and [18F]DCFPyL PET/MR-detected distant disease


Other Outcome Measures:
  1. [18F]DCFPyL PET/MR and PET/CT comparison [ Time Frame: 3 years ]
    To determine concordance and compare performance between [18F]DCFPyL PET/MR and PET/CT

  2. Concordance of PET-MR/CT finding and histological confirmation of metastatic foci. [ Time Frame: 3 years ]
    To determine the concordance of PET-MR/CT findings and histological confirmation of metastatic foci.

  3. Biomarker correlates [ Time Frame: 3 years ]
    To explore blood, urine and tissue biomarker correlates of imaging features and radiotherapy tumour resposnse.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • ECOG performance status of 0-2
  • Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches
  • No prior history of non-skin malignancy, unless treated curatively and deemed without evidence of disease for at least 5 years
  • Histological evidence of prostate adenocarcinoma on previous radical prostatectomy.
  • No use of any form of hormonal therapy in the previous 12 months, or intention to start HT at time of enrollment.
  • Normal serum testosterone level ascertained within 4-6 weeks of enrollment
  • Absence of known metastatic disease
  • Radiological studies without evidence of regional or distant metastases: CT abdomen-pelvis and bone scan within previous 3 months
  • Able to lie supine at least 60 minutes to comply with imaging and treatment.
  • Absence of impaired renal function (calculated GFR > 30mL/min)
  • Absence of sickle cell disease or other hemoglobinopathies
  • No other medical conditions deemed by the PI to make patient ineligible for PET/MR scanning or SABR

No contraindications to MRI:

  • Subject must weigh <136kg (scanner weight limit)
  • Subject must not have pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI
  • Prior anaphylactic reaction to gadolinium

Rising PSA after maximal local therapies (radical prostatectomy and either adjuvant or salvage radiotherapy):

  • Three documented PSA rises, at least 1 month apart from post radiotherapy.
  • PSA value >0.4 and < 3 ng/mL, within 4-6 weeks of enrollment
  • No use of any forms of ADT in the previous 12 months nor contemplated to be used at time of study enrollment. Salvage ADT to be started when PSA reaches a value of 6.0ng/ml or greater.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160794


Contacts
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Contact: Alejandro Berlin, MD 416-946-4501 ext 2126 alejandro.berlin@rmp.uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Alejandro Berlin, MD    416-946-4501 ext 5813    alejandro.berlin@rmp.uhn.ca   
Principal Investigator: Alejandro Berlin, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Alejandro Berlin, MD Princess Margaret Cancer Centre - University Health Network

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03160794     History of Changes
Other Study ID Numbers: 16-5532
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University Health Network, Toronto:
Prostate cancer
stereotactic ablative radiotherpy
PET/MR

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases