Hypofractionated radiotherapy for prostate cancer after surgery

Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer

This study is testing a new type of radiation treatment for men with prostate cancer who have had surgery to see if it is safe and helps them stay healthy longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06335693 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men with pathologically confirmed prostate cancer who have undergone radical prostatectomy and exhibit high-risk pathological factors.

Not a fit: Patients with poor recovery of continence after surgery or those with a history of pelvic and abdominal radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for prostate cancer patients post-surgery.

How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy in prostate cancer, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Huojun Zhang, PhD

Conditions Prostate Cancer