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HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.
Specific aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYPO-RT-PC boost | Experimental | Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-hypofractionated radiotherapy regimen. | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3+ Genitourinary Adverse Events | Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | start of treatment - 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 2+ Genitourinary Adverse Events | Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0. | start of treatment - 5 years |
| Failure-free survival | consent date - 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adalsteinn Gunnlaugsson, MD, PhD | Contact | +46 4617 6268 | Adalsteinn.Gunnlaugsson@skane.se | |
| HYPO-RT-PC boost Clinical Trials Office | Contact | +46 4617 8559 | cto.hematologi_onkologi.se@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Adalsteinn Gunnlaugsson, MD, PhD | Region Skåne, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Skåne, Skåne University Hospital | Recruiting | Lund | Sweden |
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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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| Local failure-free survival | enrollment date - 5 years |
| Biochemical failure-free survival | enrollment date - 5 years |
| Cancer-specific survival | enrollment date - 5 years |
| Overall survival failure-free survival, cancer-specific survival, and overall survival | enrollment date - 5 years |
| Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival | enrollment date - 5 years |
| Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival | enrollment date - 5 years |
| Adverse Events according to CTCAE v5.0 | start of treatment - 5 years |
| Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30) | All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems | inclusion date - 5 years |
| Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25) | It includes subscales assessing urinary symptoms, bowel symptom), treatment-related symptom) and sexual functioning with score from 0 to 4 per item. A high scale score represents a higher response level. | inclusion date - 5 years |
| Region Västerbotten, Umeå University Hospital | Recruiting | Umeå | Sweden |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |