Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer

Localized Prostate Cancer Clinical Trial

Official title:

Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325995
• Other study ID #: Changhai HHHospital
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2030

Study information

• Verified date: March 2024
• Source: Changhai Hospital
• Contact: Huojun Zhang
• Phone: 021-31162222
• Email: huojunzh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: October 1, 2030
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Conventional radiation therapy
66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
• Hypofractionated radiation therapy
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.

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events	Common Terminology Criteria for Adverse Events (CTCAE) 5.0	Assessment toxicities parameters at 5 years
Secondary	5-year progression-free survival (PFS)	To assess progression-free survival (PFS) including biochemical progression-free survival (bPFS), and radiological progression-free survival.	Assessment progression-free survival (PFS) at 5 years
Secondary	quality of life (QoL)	Expanded Prostate Cancer Index (EPIC-26):The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL.	through study completion, an average of 5 years
Secondary	medical expenses	The medical expenses during the time of interventions.The medical expenses include the payments of doctor and hospital visits, co-pays, radiotherapy and so on.	Assessment the medical economics during the treatment,up to 7 weeks
Secondary	Overall survival (OS)	To assess the overall survival (OS)	Assessment overall survival (OS) at 5 years
Secondary	Prostate cancer-specific survival	To assess the prostate cancer-specific survival	Assessment prostate cancer-specific survival at 5 years