Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Ultra-hypofractionated radiotherapy regimen.

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adalsteinn Gunnlaugsson, MD, PhD; Phone Number: +46 4617 6268; Email: Adalsteinn.Gunnlaugsson@skane.se
• Study Contact Backup: Name: HYPO-RT-PC boost Clinical Trials Office; Phone Number: +46 4617 8559; Email: cto.hematologi_onkologi.se@skane.se

Study Locations

• Sweden
  • Lund, Sweden
    • Recruiting
    • Region Skåne, Skåne University Hospital
    • Contact: Adalsteinn Gunnlaugsson, MD, PhD; Phone Number: +46 4617 6268; Email: Adalsteinn.Gunnlaugsson@skane.se
    • Contact: Clinical Trials Office; Email: cto.hematologi_onkologi.se@skane.se
  • Umeå, Sweden
    • Recruiting
    • Region Västerbotten, Umeå University Hospital
    • Contact: Karin Söderkvist, MD, PhD; Phone Number: +46907851000; Email: karin.soderkvist@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HYPO-RT-PC boost; Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 3+ Genitourinary Adverse Events	Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	start of treatment - 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 2+ Genitourinary Adverse Events	Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.	start of treatment - 5 years
Failure-free survival		consent 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
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
Adverse Events according to CTCAE v5.0		start of treatment - 5 years
Local failure-free 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 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	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.	inclusion date - 5 years

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Adalsteinn Gunnlaugsson, MD, PhD, Region Skane, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: radiotherapy; very high risk prostate cancer; localized prostate cancer treatment; ultra-hypofractionated radiation boost
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HYPO-RT-PC boost

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No