Adjuvant Hypofractionated Radiotherapy for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer
Overview
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).
Interventions
- Other Radiotherapy
The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions.
Primary outcome measures
- Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events [Time frame: through study completion, an average of 3 years]
Secondary outcome measures (5)
- progression-free survival (PFS) [Time frame: Assessment progression-free survival (PFS) at 3 years]
- medical expenses [Time frame: through study completion, an average of 3 years]
- quality of life(QoL) [Time frame: through study completion, an average of 3 years]
- overall survival (OS) [Time frame: Assessment overall survival (OS) at 3 years]
- prostate cancer-specific survival (CSS) [Time frame: Assessment prostate cancer-specific survival (CSS) at 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Naval Medical University — Shanghai
Identifiers
NCT: NCT06335693 · CHHHospital