Prostate Cancer
Conditions
Brief summary
PSMA PET/CT has demonstrated higher sensitivity in detecting metastases than current imaging standard of care (CT and bone scan). \[18F\]DCFPyL is a promising high-sensitivity second generation PSMA-targeted urea-based PET probe. The hypothesis is that definitive radiotherapy (RT) informed by PSMA-PET findings will lead to improved cancer control outcomes compared to RT guided by conventional staging only. This study utilizes cmRCT design in companion to PERA (Partnership initiative for the Evaluation of technological innovation in Radiotherapy).
Interventions
RADIATIONPSMA -PET/CT simulation
* PET/CT simulation. * If no additional lesions detected: RT as planned per standard care. * If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT. * If PSMA-PET/CT imaging consistent with widely metastatic disease (\>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged.
RADIATIONStandard-care simulation
No PSMA-PET/CT as part of RT treatment planning.
Sponsors
Progenics Pharmaceuticals, Inc.
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients are randomly selected from a standard-care cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Enrolled in PERA (CHUM CER 17.0.32) and consented to contact for investigational trials. 2. Histological diagnosis of prostate cancer planned for curative-intent radiotherapy. 3. ECOG 0-1 4. Charlson Cormobidity Index ≤ 4 5. High-risk of distant metastases as defined by any of: 1. Oligometastases (≤5) (regional or distant) identified on conventional staging, with ≤ 3 metastasis in any non-bone organ. For a spine metastasis, direct involvement of adjacent spinal segments would still be considered as one tumour. For nodal metastases, more than one involved lymph node in the same ipsilateral nodal region/chain would still count as one tumour. Defined nodal regions for this protocol include inguinal, external iliac, internal iliac, common iliac, retroperitoneal, hilar/mediastinal, anterior cervical, posterior cervical, and axillary. Metastases in all other organs that are within 1cm of each other will be considered as one tumour. 2. Subjects with newly diagnosed high-risk (NCCN) localized prostate cancer and CAPRA score 6-10. 3. Subjects with a prior history of treated prostate cancer (RP or RT), and biochemical failure (Phoenix-RT or\>0.2ng/ml-RP) 6. Standard staging (bone scan, CT pelvis) within 12 weeks of consent.
Exclusion criteria
1. Prior androgen deprivation therapy terminated \< 12 months prior to enrollment. 2. Prior or planned PET scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | 5 years | Time to failure event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and delayed toxicities | 5 years | Rate of Attributable Gr2+ toxicities (CTCAE v4.0) |
| Rate of failure | 5 years | Event rates |
| Survival | 5 years | Event rates |
| Health-related quality of life | 5 years | Qol measures |
| Detection yield of PSMA PET imaging | 2 years | Rate of new lesions identified on imaging |
Countries
Canada
Outcome results
None listed