Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

Launched by CHANGHAI HOSPITAL · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of radiation treatment called hypofractionated radiotherapy for men with prostate cancer who have recently had surgery to remove the prostate (radical prostatectomy). The goal of the trial is to see if this new radiation therapy is safe and effective for patients after their surgery. Researchers are looking for men aged 65 to 74 who have specific types of prostate cancer, as confirmed by their medical evaluations, and who are healthy enough to participate in the study.

To be eligible, participants should be in relatively good health (rated as ECOG performance status 0-2) and have specific conditions following surgery, such as certain levels of prostate-specific antigen (PSA) in their blood. They should also expect to live for at least five more years. Those who are recovering poorly from surgery, have had previous radiation treatments, or have other serious health issues may not be able to join. If you participate, you can expect close monitoring and follow-up care throughout the study. This trial is currently recruiting participants, and joining could help further our understanding of how this new treatment works for prostate cancer.

Gender

MALE

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.