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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular Imaging Informed Radiation Dose Escalation and De-escalation | Experimental | Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-guided Radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation-induced Acute Grade ≥2 Toxicity | 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. | Baseline to 5-year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and Late GI and GU toxicities | 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. | Estimated at 6 months and 2 years following treatment |
| Local Recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew McPartlin, MD | Contact | 416-946-4501 | 4855 | andrew.mcpartlin@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network - Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
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|
Cumulative incidence function with death as a competing risk will be used to estimate local recurrence |
| Estimated at 2 years and 5 years following treatment |
| Biochemical Disease Free Survival | 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 | Estimated at 2 years and 5 years following treatment |
| Patient-reported quality-of-life assessed by EPIC-26 and IPSS | 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 | Baseline to 5-year follow-up |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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