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

Launched by REGION SKANE · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called HYPO-RT-PC boost, is studying a new way of giving radiation therapy to men with a specific type of prostate cancer known as localized prostate cancer at high risk of spreading. The goal is to see how safe and effective a special kind of radiation treatment is, which is guided by real-time imaging to target the tumor directly while also treating nearby lymph nodes. This trial is currently looking for male participants between the ages of 65 and 74 who have a good chance of living for at least five more years and meet certain health criteria.

To be eligible for the trial, participants must have histologically confirmed prostate cancer that falls into the very high-risk category according to national standards. This includes factors like a specific type of tumor, high Gleason scores (which indicate how aggressive the cancer is), or high levels of a substance called PSA in the blood. Potential participants should also have some detectable lesions on an MRI scan. If you join the trial, you will receive the new radiation treatment and will closely monitor your health throughout the study. Remember, this trial has specific requirements, so it’s essential to discuss your eligibility with your healthcare provider.

Gender

MALE

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)