NCT06325995 Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
| NCT ID | NCT06325995 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Localized Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 428 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 428 participants in total. It began in 2024-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06325995 clinical trial?
This trial is open to male participants only, studying Localized Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06325995 currently recruiting?
Yes, NCT06325995 is actively recruiting participants. Contact the research team at huojunzh@163.com for enrollment information.
Where is the NCT06325995 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06325995 clinical trial?
NCT06325995 is sponsored by Changhai Hospital. The trial plans to enroll 428 participants.
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