NCT06335693Recruiting
Adjuvant Hypofractionated Radiotherapy for Prostate Cancer
Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer
Source: ClinicalTrials.gov · Last updated 28 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 17 Mar 2024
- Start date
- 28 Mar 2024
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Changhai Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06335693
What you commit to
- Study type: Interventional
- Planned participants: 9
- From 28 Mar 2024 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 radiotherapy-related contraindications.
Other illness
- Patients with a history of pelvic and abdominal radiotherapy.
- 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.
Other
- Patients with poor recovery of continence after radical prostatectomy.
- Patients who cannot provide written informed consent and have poor adherence to treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Naval Medical University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.