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

NCT06325995 | Recruiting

• 1 other identifier: Changhai HHHospital
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 5-year progression-free survival (PFS)

  Assessment progression-free survival (PFS) at 5 years

• quality of life (QoL)

  through study completion, an average of 5 years

• medical expenses

  Assessment the medical economics during the treatment,up to 7 weeks

• Overall survival (OS)

  Assessment overall survival (OS) at 5 years

• Prostate cancer-specific survival

  Assessment prostate cancer-specific survival at 5 years

Study Arms (2)

A (COPORT)

ACTIVE COMPARATOR

COPORT over 7 weeks.

Radiation: Conventional radiation therapy

B（HYPORT）

EXPERIMENTAL

HYPORT over 5 weeks.

Radiation: Hypofractionated radiation therapy

Interventions

Conventional radiation therapy RADIATION

66-74 Gy in 33-37 daily fractions of 2 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.

A (COPORT)

Hypofractionated radiation therapy RADIATION

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.

B（HYPORT）

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Central Study Contacts

Huojun Zhang

CONTACT

021-31162222; huojunzh@163.com

Xianzhi Zhao

CONTACT

021-31162222; zhxzh0007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 22, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 5 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists and specialists in surgery who are interested in examining the efficacy and toxicity of localized prostate cancer treated with HYPORT or COPORT. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)