Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultra-hypofractionated radiotherapy regimen..
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
Overview
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
- Radiation Ultra-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
Primary outcome measures
- Grade 3+ Genitourinary Adverse Events [Time frame: start of treatment - 5 years]
Secondary outcome measures (11)
- Grade 2+ Genitourinary Adverse Events [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]
- 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) [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) [Time frame: inclusion date - 5 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Region Skåne, Skåne University Hospital — Lund
- Region Västerbotten, Umeå University Hospital — Umeå
Identifiers
NCT: NCT06220435 · HYPO-RT-PC boost