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

Last updated: September 12, 2024
Sponsor: Region Skane
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

Ultra-hypofractionated radiotherapy regimen.

Clinical Study ID

NCT06220435
HYPO-RT-PC boost
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 highrisk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L orand/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 ondiagnostic 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

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 Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: Ultra-hypofractionated radiotherapy regimen.
Phase:
Study Start date:
September 25, 2023
Estimated Completion Date:
September 01, 2031

Study 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.

Connect with a study center

  • Region Skåne, Skåne University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Region Västerbotten, Umeå University Hospital

    Umeå,
    Sweden

    Active - Recruiting

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