Ablative radiotherapy for recurrent prostate cancer after surgery
Phase II Study: [18F]DCFPyL PET/MRI for Personalizing Prostate Cancer Subclinical Metastatic Ablative MR-guided Radiotherapy (MRgRT)
NA · University Health Network, Toronto · NCT03160794
This study is testing a new way to find and treat recurring prostate cancer in men who have had surgery by using advanced imaging techniques and targeted radiation therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03160794 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the detection and treatment of recurrent prostate cancer in men who have undergone prostatectomy. By using a combination of advanced whole-body MR imaging and a high-sensitivity PET probe specific to prostate cancer, the study seeks to accurately locate tumor deposits that may not be visible through standard imaging techniques. Once identified, these tumors will be treated with image-guided stereotactic ablative radiotherapy (SABR), which has shown promising results in eradicating tumors with minimal side effects. The study also aims to explore new biomarkers and prognostic tests related to the disease.
Who should consider this trial
Good fit: Ideal candidates are men with a history of prostate adenocarcinoma who have undergone radical prostatectomy and are experiencing rising PSA levels without evidence of metastatic disease.
Not a fit: Patients with significant comorbidities, a history of non-skin malignancies, or those currently undergoing hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients with recurrent prostate cancer, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies utilizing advanced imaging techniques and SABR have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Alejandro Berlin, MD — Princess Margaret Cancer Centre - University Health Network
- Study coordinator: Alejandro Berlin, MD
- Email: alejandro.berlin@rmp.uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Prostatectomy, Prostate cancer, stereotactic ablative radiotherpy, PET/MR