Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · May 18, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new way to find and treat recurring prostate cancer in men who have already undergone surgery to remove their prostate. When prostate cancer comes back after treatment, standard tests like bone scans and CT scans often miss the location of the cancer. In this trial, researchers are using a special type of imaging called MR (magnetic resonance) combined with a new PET scan that targets specific prostate cancer markers. This approach aims to accurately locate the cancer and treat it with a focused form of radiotherapy known as stereotactic ablative radiotherapy (SABR), which has shown promising results in destroying tumors while causing minimal side effects.

To participate in this study, men aged 65 to 74 who have rising PSA levels (a marker for prostate cancer) after surgery and radiation may be eligible, provided they meet certain health criteria. Key requirements include having no major health issues that would prevent treatment, no other types of cancer, and normal kidney function. Participants can expect to undergo advanced imaging to identify cancer spots, followed by targeted treatment. The hope is that this innovative approach will lead to better outcomes for men facing recurrent prostate cancer at an early stage, potentially changing the way we treat this disease.

Gender

MALE

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.