To hear about similar clinical trials, please enter your email below

Trial Title: Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

NCT ID: NCT06335693

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Radiotherapy
Description: The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions.
Arm group label: adjuvant hypofractionated radiotherapy

Summary: 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.

Detailed description: The present study will be conducted as a prospective, prospective, single-centre, single-arm clinical trial. Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions. The primary endpoint of the study is incidence of radiotherapy-related gastrointestinal and genitourinary adverse events,judging by (CTCAE)5.0. The secondary endpoints are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS), economic evaluations, self-assessment of quality of life including Abbreviated Version of the Expanded Prostate Cancer In-dex Composite Instrument (EPIC-26) and Physical Activity Rank Scale-3 (ARS-3), overall survival (OS) and prostate cancer-specific survival (CSS).

Criteria for 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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Naval Medical University

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Huojun Zhang, PhD

Phone: 021-31162222
Email: huojunzh@163.com

Start date: March 28, 2024

Completion date: February 28, 2027

Lead sponsor:
Agency: Changhai Hospital
Agency class: Other

Source: Changhai Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06335693

Login to your account

Did you forget your password?