Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Ultra-hypofractionated radiotherapy regimen.
- Registration Number
- NCT06220435
- Lead Sponsor
- Region Skane
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 76
- Life expectancy >5 years
- Age ≥18 years
- World Health Organization (WHO) performance status 0-2
- Histological evidence of prostate cancer
- Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
- At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
- Patients must be able to comply with the protocol
- Signed informed consent
- Adequate laboratory findings: haemoglobin (Hb) >90 g/L, absolute neutrophil count >1.0x10^9/l, platelets >75x10^9/l, bilirubin <2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <2.0x ULN)
- Regional or distant metastasis
- Any contraindications for MRI
- PSA >150 ng/ml
- Previous pelvic radiotherapy
- Prior prostate surgery including transurethral resection of the prostate (TURP)
- Endocrine treatment (past or present)
- Other malignancies than prostate cancer and basalioma in the past five years
- Serious disease state that makes study inclusion and treatment unsuitable
- Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HYPO-RT-PC boost Ultra-hypofractionated radiotherapy regimen. Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.
- Primary Outcome Measures
Name Time Method Grade 3+ Genitourinary Adverse Events start of treatment - 5 years Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Secondary Outcome Measures
Name Time Method 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 Failure-free survival consent date - 5 years Grade 2+ Genitourinary Adverse Events start of treatment - 5 years Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.
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) inclusion date - 5 years 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
Local failure-free 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 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) inclusion date - 5 years 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.
Trial Locations
- Locations (2)
Region Skåne, Skåne University Hospital
🇸🇪Lund, Sweden
Region Västerbotten, Umeå University Hospital
🇸🇪Umeå, Sweden