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Trial Title:
Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
NCT ID:
NCT06325995
Condition:
Localized Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Conventional radiation therapy
Description:
66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease
progression or unacceptable toxicity.
Arm group label:
A (COPORT)
Intervention type:
Radiation
Intervention name:
Hypofractionated radiation therapy
Description:
57.5-65 Gy in 23-26 daily fractions of 2.5 Gy to the prostate bed in the absence of
disease progression or unacceptable toxicity.
Arm group label:
B(HYPORT)
Summary:
The aim of this trial is to compare the safety outcomes of Hypofractionated
postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy
radiotherapy(COPORT) in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of HYPORT for localized
prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT
is still on its way.
It is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy )
with or COPORT may work better in treating patients with prostate cancer.
Detailed description:
The present study will be conducted as a prospective, open-label, two arms clinical
trial.
Patients with pathologically confirmed prostate cancer and completed radical resection of
prostate cancer, will be randomized in a 1:1 ratio between arm A (COPORT) and arm B
(HYPORT).
The patients in arm A will receive COPORT(66-74 Gy in 33-37 daily fractions of 2 Gy ).
The patients in arm B will receive HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy
). After completion of study treatment, patients were followed up once a month for the
first 3 months and once every 3 months after 3 months for a total of 5 years.
The primary endpoints of the study are toxicities parameters.The secondary endpoints
include ,progression-free survival (PFS),medical economics,quality of life (QoL), overall
survival (OS)and prostate cancer-specific survival period. The progression-free survival
(PFS) including biochemical progression-free survival (bPFS), and radiological
progression-free survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- European Cooperative Oncology Group score(ECOG):≤ 2;
- Patients with pathologically confirmed prostate cancer and completed radical
resection of prostate cancer;
- Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+),
or N1; or serum PSA≥0.1 ng/ml 6 weeks after surgery; or serum PSA <0.1 ng/ml 6 weeks
after surgery, subsequent follow-up process revealed two consecutive sustained PSA
increases (≥0.1 ng / ml) and no clinical imaging (Whole Body Scan (ECT), magnetic
resonance imaging (MRI),68Ga PSMA PET / CT, etc.) signs of metastasis;
- Expected survival time >5 years;
- Patients who voluntarily accept the experimental study protocol after informing the
existing treatment options;
Exclusion Criteria:
- poor recovery of postoperative urinary control;
- a previous history of pelvic and abdominal radiotherapy;
- Participate in other clinical trials that are mutually exclusive with the study
intervention within 4 weeks prior to the start of the study;
- Patients with other malignancies and acute or chronic infections such as human
immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive
syphilis;
- Patients that the investigator considers unsuitable to participate in the clinical
trial; patients with other serious systemic diseases, evaluation and compliance of
the trial, including severe respiratory, circulatory, neurological, mental,
digestive, endocrine, immune, urinary, and other systemic diseases;
- Patients with contraindications related to radiotherapy;
- Written informed consent could not be provided, and treatment compliance was
poor.Patients unsuitable for participation in this clinical trial as per the
judgement of the investigator.
Gender:
Male
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Huojun Zhang, M.D.
Phone:
+8613311732399
Email:
chyyzhj@163.com
Investigator:
Last name:
Huojun Zhang, M.D.
Email:
Principal Investigator
Start date:
February 1, 2024
Completion date:
February 1, 2031
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06325995