Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

NCT ID: NCT03160794

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-23
• Study Completion Date: 2027-09-30

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.

Conditions

Post Prostatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[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.

Group Type: EXPERIMENTAL

[18F]DCFPyL PET/MRI scan

Intervention Type: DIAGNOSTIC_TEST

PET/MRI imaging using the radiotracer, \[18F\]DCFPyL

Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

SABR as treatment for lesions identified using \[18F\]DCFPyL PET/MRI

Interventions

[18F]DCFPyL PET/MRI scan

PET/MRI imaging using the radiotracer, \[18F\]DCFPyL

Intervention Type: DIAGNOSTIC_TEST

Stereotactic Ablative Radiotherapy

SABR as treatment for lesions identified using \[18F\]DCFPyL PET/MRI

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Berlin, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre - University Health Network

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Alejandro Berlin, MD

Role: CONTACT

alejandro.berlin@rmp.uhn.ca

416-946-4501 ext. 2126

Facility Contacts

Alejandro Berlin, MD

Role: primary

alejandro.berlin@rmp.uhn.ca

416-946-4501 ext. 5813

References

Glicksman RM, Metser U, Valliant J, Chung PW, Fleshner NE, Bristow RG, Green D, Finelli A, Hamilton R, Stanescu T, Hussey D, Catton C, Gospodarowicz M, Warde P, Bayley A, Breen S, Vines D, Jaffray DA, Berlin A. [18F]DCFPyL PET-MRI/CT for unveiling a molecularly defined oligorecurrent prostate cancer state amenable for curative-intent ablative therapy: study protocol for a phase II trial. BMJ Open. 2020 Apr 22;10(4):e035959. doi: 10.1136/bmjopen-2019-035959.

Reference Type: DERIVED

PMID: 32327479 (View on PubMed)

Other Identifiers

16-5532

Identifier Type: -

Identifier Source: org_study_id