Prostate Cancer
Conditions
Keywords
Prostate Cancer, adenocarcinoma, PSMA PET, radical prostatectomy, recurrence
Brief summary
This is a Phase II prospective single-arm trial that is recruiting 80 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.
Interventions
RADIATIONImage-guided Radiotherapy
de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men older than 18 years old. * Histologically proven initial diagnosis of adenocarcinoma prostate cancer. * Previous radical prostatectomy. * Biochemical relapse with local or regional recurrence proven on PSMA PET. * Five or less positive nodes on the PSMA PET. * ECOG 0-1
Exclusion criteria
* Presence of para-aortic lymph nodes or distant metastasis. * Chronic pelvic inflammatory disease. * Contraindication for radiation treatment. * Previous radiation treatment within the pelvis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade ≥2 Toxicity for GU | Baseline to 5-year follow-up | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Failure Free Survival | Baseline to 5-year follow-up | Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels |
| Patient-reported quality-of-life assessed by EPIC-26 | Baseline to 5-year follow-up | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) |
Countries
Canada
Contacts
CONTACTAndrew McPartlin, MD
Outcome results
None listed