Hypofractionated radiotherapy for prostate cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of hypofractionated radiotherapy as an adjuvant treatment for patients with prostate cancer who have undergone radical prostatectomy. It is a prospective, single-centre, single-arm trial where participants with high-risk pathological factors will receive radiotherapy in 15 fractions. The primary focus is on assessing the incidence of gastrointestinal and genitourinary adverse events, while secondary endpoints include progression-free survival, quality of life assessments, and overall survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ECOG performance status 0-2.
2. Pathologically confirmed prostate cancer and completion of radical prostatectomy.
3. Postoperative pathological staging pT 3a, pT 3b, pT 4, surgical margins (+) or N1; or serum PSA ≥0.1ng/ml at 6 weeks postoperatively; or serum PSA \<0.1ng/ml at 6 weeks postoperatively, with two consecutive persistently elevated PSA (≥0.1ng/ml) without signs of metastasis on clinical imaging (whole-body bone scan (ECT), magnetic resonance imaging (MRI), 68Ga PSMA PET/CT, etc.) .
4. Expected survival time \>5 years.
5. Voluntarily accepted this experimental study protocol after being informed of the available treatment options.

Exclusion Criteria:

1. Patients with poor recovery of continence after radical prostatectomy.
2. Patients with a history of pelvic and abdominal radiotherapy.
3. Patients who participated in other clinical trials that were repugnant to the intervention of this trial within 4 weeks prior to the start of this trial.
4. Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis.
5. Patients who are deemed unfit to participate in this clinical trial in the judgement of the investigator, for instance, patients with serious systemic diseases that, in the judgement of the investigator, may interfere with the treatment and evaluation of this trial and its compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, urological and other systemic diseases.
6. Patients with radiotherapy-related contraindications.
7. Patients who cannot provide written informed consent and have poor adherence to treatment.

Where it's running

• The First Affiliated Hospital of Naval Medical University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Huojun Zhang, PhD
• Email: huojunzh@163.com
• Phone: 021-31162222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.