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New treatment option for Prostate Cancer
Official title Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
ClinicalTrials.gov ID: NCT06220435
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
You likely can't join 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)
See the full eligibility 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
- Umeå, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden; Umeå, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.