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Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Primary Purpose

Post Prostatectomy

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

[18F]DCFPyL PET/MRI scan

Stereotactic Ablative Radiotherapy

About this trial

This is an interventional diagnostic trial for Post Prostatectomy focused on measuring Prostate cancer, stereotactic ablative radiotherpy, PET/MR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F] DCFPyL PET/MRI

Arm Description

[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.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Correlation between PSA kinetics and PET imaging parameters

To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)

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

Full Information

NCT ID

NCT03160794

First Posted

May 18, 2017

Last Updated

May 7, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03160794

Brief Title

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 23, 2017 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Prostatectomy

Keywords

Prostate cancer, stereotactic ablative radiotherpy, PET/MR

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[18F] DCFPyL PET/MRI

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

[18F]DCFPyL PET/MRI scan

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Ablative Radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

Endpoint: Detection rates and performance metrics of [18F]DCFPyL PET-MR/CT in the post-prostatectomy plus adjuvant/salvage RT setting.

Time Frame

3 years

Title

Description

Time Frame

3 Years

Secondary Outcome Measure Information:

Title

Correlation between PSA kinetics and PET imaging parameters

Description

To explore the correlation between PSA kinetics and PET imaging parameters (SUV, dynamic data, volumetric studies)

Time Frame

6 months post SABR

Title

Correlate between tissue biomarker and distant disease

Description

To explore the correlation between tissue biomarkers from prostatectomy specimen (e.g. genomic signatures) and [18F]DCFPyL PET/MR-detected distant disease

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

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

Description

To determine concordance and compare performance between [18F]DCFPyL PET/MR and PET/CT

Time Frame

3 years

Title

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

Description

To determine the concordance of PET-MR/CT findings and histological confirmation of metastatic foci.

Time Frame

3 years

Title

Biomarker correlates

Description

To explore blood, urine and tissue biomarker correlates of imaging features and radiotherapy tumour resposnse.

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alejandro Berlin, MD

Phone

416-946-4501

Ext

2126

alejandro.berlin@rmp.uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandro Berlin, MD

Organizational Affiliation

Princess Margaret Cancer Centre - University Health Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandro Berlin, MD

Phone

416-946-4501

Ext

5813

alejandro.berlin@rmp.uhn.ca

First Name & Middle Initial & Last Name & Degree

Alejandro Berlin, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32327479

Citation

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.

Results Reference

derived

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Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

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