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This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive SBRT with Urethral Sparing | Experimental | Daily adaptive stereotactic body radiation therapy delivering 40 Gy in 5 fractions to the prostate while delivery 35-36 Gy in 5 fractions to the urethra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily adaptive SBRT with urethral sparing | Device | The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported acute urinary toxicity | Minimum clinically important change (MCIC) status in patient-reported urinary QOL, as determined by the worst change reported by each subject in their EPIC-26 urinary domain scores. | 90 days after end of SBRT |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from biochemical recurrence | Rate of biochemical recurrence free survival, as determined by the Phoenix definition (PSA level of 2 ng/ml or more higher than the lowest post-SBRT value) | 5 years after end of SBRT |
| Patient-reported quality of life issues related to prostate cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Decipher prognostic ability | Correlation of the Decipher risk category (low/intermediate/high) with biochemical recurrence. | 5 years after end of SBRT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sean Davidson, MASc | Contact | 1-437-991-8294 | sean.davidson@siemens-healthineers.com | |
| Claire McCann, PhD | Contact | claire.mccann@siemens-healthineers.com |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Leeman, MD | Brigham and Women's Hospital | Principal Investigator |
| Jeremy Bredfeldt, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duarte Cancer Center | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patient-reported quality of life changes during and after adaptive prostate SBRT treatment using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) questionnaire. |
| Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Patient-reported erectile dysfunction symptoms | Patient-reported erectile dysfunction symptoms before, during and after adaptive prostate SBRT treatment using the Sexual Health Inventory for Men (SHIM) questionnaire. | Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Patient-reported urinary symptoms | Patient-reported urinary symptoms before, during and after adaptive prostate SBRT treatment using the International Prostate Symptom Score (IPSS) questionnaire. | Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Patient-reported overall quality of life | Patient-reported overall quality of life before, during and after adaptive prostate SBRT treatment using the EQ-5D-5L questionnaire. | Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Physician-reported toxicities | Physician-reported CTCAE v 5.0 adverse events | During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Alpha-blocker medication use | Change in use of alpha-blocker medications for urinary symptoms | Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT |
| Metastasis-free survival | Metastasis-free survival | 5 years after end of SBRT |
| Prostate-cancer specific mortality | Prostate-cancer specific mortality | 5 years after end of SBRT |
| Overall survival | Overall survival | 5 years after end of SBRT |
| Workflow metrics of adaptive SBRT for prostate cancer | Includes the time on table and frequency of using the adapted vs. non-adapted treatment plan for each fraction. | 2 weeks after start of SBRT |
| Target and OAR dosimetry | Improvement in target coverage and/or reduction in dose to critical organs at risk in the adapted plan compared to the non-adaptive planned dosimetry | 2 weeks after start of SBRT |
| Impact of rectal spacers | Physician reported toxicity and patient reported outcomes with or without implanted resorbable rectal spacer | Enrollment through 5 year follow up |
| City of Hope Orange County Lennar Foundation Cancer Center | Recruiting | Irvine | California | 92618 | United States |
|
| Brigham and Women's Hospital | Active, not recruiting | Boston | Massachusetts | 02115 | United States |
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Fox Chase Cancer Center | Active, not recruiting | Philadelphia | Pennsylvania | 19111 | United States |
| Klinikum der Landeshauptstadt Stuttgart gKAöR | Recruiting | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
|
| Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) | Recruiting | Homburg | Saarland | 66421 | Germany |
|
| Hospital Universitario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |