NCT06220435

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
65mo left

Started Sep 2023

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2023Sep 2031

Study Start

First participant enrolled

September 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

August 12, 2025

Status Verified

July 1, 2025

Enrollment Period

7.9 years

First QC Date

January 10, 2024

Last Update Submit

August 10, 2025

Conditions

Prostate Cancer

Keywords

very high risk prostate cancerradiotherapylocalized prostate cancer treatmentultra-hypofractionated radiation boost

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Grade 2+ Genitourinary Adverse Events

    start of treatment - 5 years

  • 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

  • +6 more secondary outcomes

Study Arms (1)

HYPO-RT-PC boost

EXPERIMENTAL

Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation.

Radiation: Ultra-hypofractionated radiotherapy regimen.

Interventions

Ultra-hypofractionated radiotherapy regimen.RADIATION

* 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

HYPO-RT-PC boost

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Region Skåne, Skåne University Hospital

Lund, Sweden

RECRUITING

Region Västerbotten, Umeå University Hospital

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Adalsteinn Gunnlaugsson, MD, PhD

    Region Skåne, Lund University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adalsteinn Gunnlaugsson, MD, PhD

CONTACT

+46 4617 6268Adalsteinn.Gunnlaugsson@skane.se

HYPO-RT-PC boost Clinical Trials Office

CONTACT

+46 4617 8559cto.hematologi_onkologi.se@skane.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 24, 2024

Study Start

September 25, 2023

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

August 12, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)