To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?