Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

NCT03160794 | Recruiting DMC

• 1 other identifier: 16-5532
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer; stereotactic ablative radiotherpy; PET/MR

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Correlation between PSA kinetics and PET imaging parameters

  6 months post SABR

• Correlate between tissue biomarker and distant disease

  3 years

Other Outcomes (3)

• [18F]DCFPyL PET/MR and PET/CT comparison

  3 years

• Concordance of PET-MR/CT finding and histological confirmation of metastatic foci.

  3 years

• Biomarker correlates

  3 years

Study Arms (1)

[18F] DCFPyL PET/MRI

EXPERIMENTAL

\[18F\] 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; Radiation: Stereotactic Ablative Radiotherapy

Interventions

[18F]DCFPyL PET/MRI scan DIAGNOSTIC_TEST

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

[18F] DCFPyL PET/MRI

Stereotactic Ablative Radiotherapy RADIATION

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

[18F] DCFPyL PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 32327479 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alejandro Berlin, MD

  Princess Margaret Cancer Centre - University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Berlin, MD

CONTACT

416-946-4501; alejandro.berlin@rmp.uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: May 23, 2017
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CA (1)