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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