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


Condition: Post Prostatectomy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03160794

Sponsor: University Health Network, Toronto

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Criteria: - ECOG performance status of 0-2 - Absence of significant comorbidities rendering patient nor suitable for curative ablative approaches - No prior history of non-skin malignancy, unless treated curatively and deemed without evidence of disease for at least 5 years - 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 >0.4 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.

View trial on ClinicalTrials.gov