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Cohort Study of Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer

Cohort Study of Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072580
Enrollment
Unknown
Registered
2023-06-18
Start date
2023-06-12
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

Cohort A(high dose boost group):The entire prostatic region ± seminal vesicles 70Gy/25f EQD2 = 81.2 Gy IDN 6-8Gy/1f (or simultaneous boost to 72.5-75Gy/25f) EQD2=92-98.8 (85.6-90) Gy
Cohort B (moderate and low dose boost group) :The entire prostatic region ± seminal vesicles 67.5-70Gy/25f EQD2=77-81.2Gy IDN 5Gy/1f (or simultaneous boost to72.5Gy/25f) EQD2=85-89.2(85.6)Gy
Cohort C (elderly patient group) :The entire prostatic region ± seminal vesicles 65Gy/25f EQD2=72.8Gy IDN 70Gy/25f EQD2=81.2Gy
Cohort D (standard dose group):The entire prostatic region ± seminal vesicles 70Gy/25f EQD2=81.2Gy

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: Overall inclusion criteria: Patients with prostate cancer admitted to Peking University First Hospital who met the admission criteria and met the following criteria: 1. Prostate cancer diagnosed by biopsy, staging cT1-4N0-1M0; 2. Body imaging (such as bone scan or PET-CT) excluding distant metastases; 3. Expected survival greater than 12 months; 4. Age >18 years old; 5. KPS>70 points; 6. White blood cells =3.0×109/l, neutrophils =1.5×109/l, platelets =75.0×109/l, hemoglobin =90g/l; 7. Patients give informed consent and sign informed consent. Unit inclusion criteria: Cohort A (high dose boost group) : Prostate biopsy found Gleason Score to contain 5 components, or age =50 years. Cohort B (moderate and low dose boost group) : Prostate biopsy was performed with Gleason Score 6-8 without 5-point component. Cohort C (elderly patient group) : =80 years of age with poor radiotherapy tolerance as assessed by the physician in charge. Cohort D (standard dose group) : No distinction was made between prostate and tumor area dose patients.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patietn who have a history of malignant tumors (except skin cancer with non-malignant melanoma and tumors that have been cured for more than 5 years); 2. Had received abdominal pelvic radiotherapy; 3. Those with existing or combined severe hemorrhagic disease; 4. There are clinically uncontrolled comorbiditions, such as toxic shock from infection, drug-uncontrolled hypertension, uncontrolled unstable angina, New York Heart Association (NYHA) =II congestive heart failure, unstable symptomatic arrhythmia, etc. 5. Those without informed consent due to psychological, family, social and other factors.

Design outcomes

Primary

MeasureTime frame
Event-free survival,EFS;

Secondary

MeasureTime frame
Distance metastasis free survival,DMFS;Overall survival, OS;Side effects and quality of life;

Countries

China

Contacts

Public ContactMing-Wei Ma

Peking University First Hospital

dr.mingweima@stu.pku.edu.cn+86 158 1016 0120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026