Actively Recruiting
Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
Led by Changhai Hospital · Updated on 2024-08-26
428
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- European Cooperative Oncology Group score (ECOG) of 2 or less
- Pathologically confirmed prostate cancer with completed radical prostatectomy
- Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, positive margin, or N1
- Serum PSA level of 0.1 ng/ml or higher 6 weeks after surgery, or serum PSA less than 0.1 ng/ml 6 weeks after surgery followed by two consecutive increases of 0.1 ng/ml or higher without signs of metastasis
- Expected survival time greater than 5 years
- Voluntary acceptance of the study protocol after being informed about existing treatment options
You will not qualify if you...
- Poor recovery of urinary control after surgery
- Previous history of pelvic or abdominal radiotherapy
- Participation in other clinical trials that conflict with this study within 4 weeks before starting
- Diagnosis of other malignancies or acute/chronic infections such as HIV, hepatitis C, or syphilis
- Presence of serious systemic diseases affecting respiratory, circulatory, neurological, mental, digestive, endocrine, immune, or urinary systems
- Contraindications to radiotherapy
- Unable to provide written informed consent or poor treatment compliance
- Investigator judgment deeming the patient unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
H
Huojun Zhang
CONTACT
X
Xianzhi Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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