Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID03160794

Phase II Study of [18F]DCFPyL PET/MRI for Personalized Radiotherapy in Recurrent Prostate Cancer After Prostatectomy and Radiotherapy

Led by University Health Network, Toronto · Updated on 2025-02-10

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a new imaging approach to detect early recurrent prostate cancer in men who have rising PSA levels after receiving radical prostatectomy and radiotherapy. The study evaluates the use of a specific PET/MRI scan with a prostate cancer-targeted radiotracer called [18F]DCFPyL to locate small metastatic tumors that standard scans usually miss. The goal is to personalize treatment by identifying and targeting these early metastases before the disease progresses further. Participants will undergo the [18F]DCFPyL PET/MRI scan to map any recurrent disease. Detected lesions will then be treated with stereotactic ablative radiotherapy (SABR), a targeted radiation therapy aimed at destroying tumor deposits with minimal side effects. This phase II study also collects tissue and imaging data to explore new biomarkers and to correlate genetic signatures from the original prostate surgery with imaging and treatment outcomes. During the study, men will be closely monitored with PSA tests and imaging assessments to evaluate the success of the targeted therapy. Researchers will measure how well the PET/MRI identifies early metastatic lesions and whether treating these lesions improves clinical outcomes. The study includes safety monitoring and follow-up over three years to assess PSA changes and the relationship between tissue biomarkers and disease progression. Participation length varies, with imaging and treatment visits occurring as needed.

CONDITIONS

Brief Title

Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Histological confirmation of prostate adenocarcinoma from prior radical prostatectomy
  • Rising PSA after maximal local therapies with three documented PSA increases at least 1 month apart
  • PSA value between 0.1 and less than 3 ng/mL within 4-6 weeks of enrollment
  • No hormonal therapy use in the past 12 months and no intention to start hormonal therapy at enrollment
  • ECOG performance status between 0 and 2
  • Normal serum testosterone level within 4-6 weeks of enrollment
  • No evidence of regional or distant metastases on recent CT abdomen-pelvis and bone scan (within 3 months)
  • Ability to lie supine for at least 60 minutes for imaging and treatment
  • Adequate renal function (glomerular filtration rate greater than 30 mL/min)
  • No history of non-skin malignancy
  • No sickle cell disease or other hemoglobinopathies
  • No contraindications to MRI such as weight over 136 kg, incompatible implants, or prior anaphylactic reaction to gadolinium
  • No other medical conditions deemed unsuitable for PET/MR scanning or SABR by the investigator
Not Eligible

You will not qualify if you...

  • Female patients
  • Evidence of metastatic disease on imaging or clinical evaluation
  • Use of any form of hormonal therapy within the previous 12 months or planned use at enrollment
  • Impaired renal function with calculated glomerular filtration rate less than or equal to 30 mL/min
  • Presence of pacemakers, cerebral aneurysm clips, shrapnel, or incompatible implantable electronic devices
  • Prior anaphylactic reaction to gadolinium contrast
  • Inability to lie supine for at least 60 minutes
  • Significant comorbidities that would make the patient unsuitable for curative ablative therapies
  • History of non-skin cancers
  • Presence of sickle cell disease or other hemoglobinopathies
  • Weight exceeding 136 kg (scanner weight limit)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 4 to 6 weeks of enrollment

Participants undergo [18F]DCFPyL PET/MRI scans to identify recurrent prostate cancer lesions after prior therapies.

1 visit (in-person)

Treatment

Duration - Duration of radiotherapy or surgical intervention as per treatment plan

Lesions identified through imaging are treated with stereotactic ablative radiotherapy (SABR) or surgery.

Approximately 1 to 2 visits depending on treatment approach

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored for clinical outcomes, PSA kinetics, and disease progression after treatment.

Periodic visits over 3 years

Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

A

Alejandro Berlin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

[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.

Rachel M Glicksman, Ur Metser, John Valliant...

https://pubmed.ncbi.nlm.nih.gov/32327479