Prostate Cancer
Conditions
Keywords
very high risk prostate cancer, radiotherapy, localized prostate cancer treatment, ultra-hypofractionated radiation boost
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.
Interventions
RADIATIONUltra-hypofractionated radiotherapy regimen.
* 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
Sponsors
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | consent date - 5 years | — |
| 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 | — |
| Grade 2+ Genitourinary Adverse Events | start of treatment - 5 years | Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0. |
| 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) | 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 |
| 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. |
| Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival | enrollment date - 5 years | — |
Countries
Sweden
Contacts
Primary ContactAdalsteinn Gunnlaugsson, MD, PhD
Backup ContactHYPO-RT-PC boost Clinical Trials Office
Outcome results
None listed