Prostate Cancer (Adenocarcinoma)
Conditions
Brief summary
This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan. This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 & IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.
Interventions
RADIATIONImage-guided Radiotherapy
* Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas with SBRT, 25Gy in 5 fractions to prostate bed +/- pelvic lymph nodes delivered every other day with a boost to PSMA avid disease of 35 Gy in 5 fraction * Treatment of pelvic lymph nodes and androgen deprivation therapy for 0-24 months at clinician discretion
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
* Age ≥ 18 years old. * Histologically proven initial diagnosis of adenocarcinoma prostate cancer. * Radical prostatectomy \> 6 months prior to commencing SBRT. * Biochemical relapse with local and/or regional recurrence proven with 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 |
|---|---|---|
| Radiation-induced Acute Grade ≥2 Toxicity | 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) v6.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and Late GI and GU toxicities | Estimated at 6 months and 2 years following treatment | Cumulative incidence function will be used to estimate the cumulative incidence of grade ≥2 GI and GU, graded per Common Terminology Criteria for Adverse Events (CTCAE) v6.0. |
| Local Recurrence | Estimated at 2 years and 5 years following treatment | Cumulative incidence function with death as a competing risk will be used to estimate local recurrence |
| Biochemical Disease Free Survival | Estimated at 2 years and 5 years following treatment | Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer |
| Patient-reported quality-of-life assessed by EPIC-26 and IPSS | Baseline to 5-year follow-up | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) using the following assessment questionnaires: EPIC-26 and IPSS |
Countries
Canada
Contacts
CONTACTAndrew McPartlin, MD
Outcome results
None listed