Adjuvant Hypofractionated Radiotherapy for Prostate Cancer
Recruiting · NCT06335693 · Interventional (participants receive a specific treatment) · Lead sponsor: Changhai Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Radiotherapy
What this trial is about
Hypofractionated radiation therapy is a new type of radiotherapy which has been shown to play a larger role in the treatment of prostate cancer. The aims of the trial were to evaluate the safety and feasibility of adjuvant hypofractionated radiotherapy following radical prostatectomy for prostate cancer.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ECOG performance status 0-2.
- Pathologically confirmed prostate cancer and completion of radical prostatectomy.
- 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.) .
- Expected survival time \>5 years.
- Voluntarily accepted this experimental study protocol after being informed of the available treatment options.
Exclusion criteria
- Patients with poor recovery of continence after radical prostatectomy.
- Patients with a history of pelvic and abdominal radiotherapy.
- 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.
- Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis.
- 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.
- Patients with radiotherapy-related contraindications.
- Patients who cannot provide written informed consent and have poor adherence to treatment.
Where it is running
1 location listed.
- The First Affiliated Hospital of Naval Medical University - Shanghai, Shanghai Municipality, China