Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Post Prostatectomy Clinical Trial

Official title:

Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03160794
• Other study ID #: 16-5532
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Alejandro Berlin, MD
• Phone: 416-946-4501
• Email: alejandro.berlin[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• ECOG performance status of 0-2
• Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches
• No history of non-skin malignancy
• 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 >0.1 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.

Related Conditions & MeSH terms

• Post Prostatectomy
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	[18F]DCFPyL PET/MR and PET/CT comparison	To determine concordance and compare performance between [18F]DCFPyL PET/MR and PET/CT	3 years
Other	Concordance of PET-MR/CT finding and histological confirmation of metastatic foci.	To determine the concordance of PET-MR/CT findings and histological confirmation of metastatic foci.	3 years
Other	Biomarker correlates	To explore blood, urine and tissue biomarker correlates of imaging features and radiotherapy tumour resposnse.	3 years
Primary	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.	Endpoint: Detection rates and performance metrics of [18F]DCFPyL PET-MR/CT in the post-prostatectomy plus adjuvant/salvage RT setting.	3 years
Primary	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.	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	3 Years
Secondary	Correlation between PSA kinetics and PET imaging parameters	To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)	6 months post SABR
Secondary	Correlate between tissue biomarker and distant disease	To explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and [18F]DCFPyL PET/MR-detected distant disease	3 years