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Trial Title:
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
NCT ID:
NCT06220435
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
very high risk prostate cancer
radiotherapy
localized prostate cancer treatment
ultra-hypofractionated radiation boost
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Ultra-hypofractionated radiotherapy regimen.
Description:
- 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
Arm group label:
HYPO-RT-PC boost
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.
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.
Criteria for 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)
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Region Skåne, Skåne University Hospital
Address:
City:
Lund
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Adalsteinn Gunnlaugsson, MD, PhD
Phone:
+46 4617 6268
Email:
Adalsteinn.Gunnlaugsson@skane.se
Contact backup:
Last name:
Clinical Trials Office
Email:
cto.hematologi_onkologi.se@skane.se
Facility:
Name:
Region Västerbotten, Umeå University Hospital
Address:
City:
Umeå
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Karin Söderkvist, MD, PhD
Phone:
+46907851000
Email:
karin.soderkvist@umu.se
Start date:
September 25, 2023
Completion date:
September 1, 2031
Lead sponsor:
Agency:
Region Skane
Agency class:
Other
Source:
Region Skane
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06220435
