Clinical trial NCT06325995: Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
Official title: Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Localized Prostate Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 428
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
timeFrame: Assessment toxicities parameters at 5 years
Secondary outcomes:
measure: 5-year progression-free survival (PFS)
timeFrame: Assessment progression-free survival (PFS) at 5 years
measure: quality of life (QoL)
timeFrame: through study completion, an average of 5 years
measure: medical expenses
timeFrame: Assessment the medical economics during the treatment,up to 7 weeks
measure: Overall survival (OS)
timeFrame: Assessment overall survival (OS) at 5 years
measure: Prostate cancer-specific survival
timeFrame: Assessment prostate cancer-specific survival at 5 years
measure: Physical Activity Rank Scale-3 (ARS-3)
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
References: