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: * To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome). * To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer. * To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
* Prostate tumor(s): 49 Gray (Gy)/7 fractions * Prostate gland: 42.7 Gy/7 fractions * Elective lymph nodes: 29.4 Gy/7 fractions * Seminal vesicles: 31.15 Gy/7 fractions
Region Skåne, Skåne University Hospital
Lund, Sweden
RECRUITINGRegion Västerbotten, Umeå University Hospital
Umeå, Sweden
RECRUITINGGrade 3+ Genitourinary Adverse Events
Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: start of treatment - 5 years
Grade 2+ Genitourinary Adverse Events
Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.
Time frame: start of treatment - 5 years
Failure-free survival
Time frame: consent date - 5 years
Local failure-free survival
Time frame: enrollment date - 5 years
Biochemical failure-free survival
Time frame: enrollment date - 5 years
Cancer-specific survival
Time frame: enrollment date - 5 years
Overall survival failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Adverse Events according to CTCAE v5.0
Time frame: start of treatment - 5 years
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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
Time frame: 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.
Time frame: inclusion date - 5 years