Actively Recruiting
Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT) for Localized Prostate Cancer: A Randomized Controlled Clinical Trial
Led by Changhai Hospital · Updated on 2024-08-26
428
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety outcomes of two types of post-prostatectomy radiotherapy for patients with localized prostate cancer. The study compares Hypofractionated postprostatectomy radiotherapy (HYPORT) with Conventionally fractionated postprostatectomy radiotherapy (COPORT) to determine which approach may work better. This clinical trial is prospective, open-label, and randomized, aiming to address the optimal radiation dose per fraction for this condition. Participants are randomly assigned to one of two groups. One group receives COPORT, which consists of 66-74 Gy delivered in 33-37 daily fractions of 2 Gy over 7 weeks. The other group receives HYPORT, which involves 57.5-65 Gy in 23-26 daily fractions of 2.5 Gy over 5 weeks. Both radiation therapies are given to the prostate bed without disease progression or unacceptable toxicity. After treatment, patients are followed monthly for 3 months, then every 3 months, for a total of 5 years. During the study, participants will undergo assessments of toxicities, quality of life, progression-free survival, overall survival, and prostate cancer-specific survival. Researchers will track physical activity and medical expenses related to treatment. Safety monitoring focuses on gastrointestinal and urogenital adverse events over 5 years. This long-term follow-up helps evaluate both safety and treatment outcomes to guide future care for localized prostate cancer.
CONDITIONS
Brief 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 prostate resection
- Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, positive 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 with two consecutive sustained PSA increases ≥0.1 ng/ml and no signs of metastasis on imaging
- Expected survival time greater than 5 years
- Voluntary acceptance of the experimental study protocol after being informed of existing treatment options
You will not qualify if you...
- Poor recovery of urinary control after surgery
- Previous history of pelvic and abdominal radiotherapy
- Participation in other conflicting clinical trials within 4 weeks before the study
- Presence of other malignancies or acute/chronic infections such as HIV, hepatitis C, or syphilis
- Serious systemic diseases that affect trial compliance, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, or urinary diseases
- Contraindications related to radiotherapy
- Unable to provide written informed consent or poor treatment compliance
- Judged unsuitable by the investigator for participation in the clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 5 to 7 weeks
Participants receive radiation therapy to the prostate bed using one of two schedules: conventional radiation therapy over 7 weeks or hypofractionated radiation therapy over 5 weeks, depending on their assigned group.
Daily visits for radiation treatment sessions
Duration - Up to 5 years
After completing radiation therapy, participants are followed to monitor toxicities, progression-free survival, quality of life, and overall health for up to 5 years.
Monthly visits for the first 3 months, then visits every 3 months thereafter
Trial Site Locations
Total: 1 location
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
H
Huojun Zhang
X
Xianzhi Zhao
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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