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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.
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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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade ≥2 Toxicity for GU | 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. | Baseline to 5-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Failure Free Survival | 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 | Baseline to 5-year follow-up |
| Patient-reported quality-of-life assessed by EPIC-26 |
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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 |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
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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) |
| Baseline to 5-year follow-up |
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D000230 | Adenocarcinoma |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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