Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: Radiotherapy

• Registration Number: NCT06335693
• Lead Sponsor: Changhai Hospital

Brief 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).

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study Start: 2024-03-28
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2026-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adjuvant hypofractionated radiotherapy	Radiotherapy	Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions.

Primary Outcome Measures

Name	Time	Method
Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events	through study completion, an average of 3 years	Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events

Secondary Outcome Measures

Name	Time	Method
quality of life(QoL)	through study completion, an average of 3 years	Expanded Prostate Cancer In-dex Composite Instrument 26 (EPIC-26) assesses 26 items in 5 areas, including urinary incontinence, urethral irritation and urethral obstruction symptoms, bowel function, sexual function, sexuality and sex hormone levels. The total score ranges from 0 to 100, with higher scores indicating better quality of life.
progression-free survival (PFS)	Assessment progression-free survival (PFS) at 3 years	including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS)
overall survival (OS)	Assessment overall survival (OS) at 3 years	To assess the overall survival (OS)
medical expenses	through study completion, an average of 3 years	Medical expenses include the cost of examination, hospitalisation, medication, radiation therapy, hospital equipment and any necessary follow-up treatment.
prostate cancer-specific survival (CSS)	Assessment prostate cancer-specific survival (CSS) at 3 years	To assess the prostate cancer-specific survival

Trial Locations

Locations (1)

The First Affiliated Hospital of Naval Medical University; 🇨🇳 Shanghai, Shanghai, China