Clinical trial NCT06220435: Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: very high risk prostate cancer
radiotherapy
localized prostate cancer treatment
ultra-hypofractionated radiation boost
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Grade 3+ Genitourinary Adverse Events
timeFrame: start of treatment - 5 years
Secondary outcomes:
measure: Grade 2+ Genitourinary Adverse Events
timeFrame: start of treatment - 5 years
measure: Failure-free survival
timeFrame: consent date - 5 years
measure: Local failure-free survival
timeFrame: enrollment date - 5 years
measure: Biochemical failure-free survival
timeFrame: enrollment date - 5 years
measure: Cancer-specific survival
timeFrame: enrollment date - 5 years
measure: Overall survival failure-free survival, cancer-specific survival, and overall survival
timeFrame: enrollment date - 5 years
measure: Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival
timeFrame: enrollment date - 5 years
measure: Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival
timeFrame: enrollment date - 5 years
measure: Adverse Events according to CTCAE v5.0
timeFrame: start of treatment - 5 years
measure: 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)
timeFrame: inclusion date - 5 years
measure: 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)
timeFrame: inclusion date - 5 years
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region Skåne, Skåne University Hospital
city: Umeå
country: Sweden
facility: Region Västerbotten, Umeå University Hospital
Study officials:
affiliation: Region Skåne, Lund University
name: Adalsteinn Gunnlaugsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: