Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Safety and Efficacy Study of Adjuvant Hypofractionated Radiotherapy Following Radical Prostatectomy for Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335693
• Other study ID #: CHHHospital
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: March 2024
• Source: Changhai Hospital
• Contact: Huojun Zhang, PhD
• Phone: 021-31162222
• Email: huojunzh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Radiotherapy
The patients after radical prostatectomy with high-risk pathological factors will receive adjuvant hypofractionated radiation therapy in 15 fractions.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Naval Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events	Incidence of radiotherapy-related gastrointestinal and genitourinary adverse events	through study completion, an average of 3 years
Secondary	progression-free survival (PFS)	including biochemical recurrence-free survival (bPFS) and radiological progression-free survival (RPFS)	Assessment progression-free survival (PFS) at 3 years
Secondary	medical expenses	Medical expenses include the cost of examination, hospitalisation, medication, radiation therapy, hospital equipment and any necessary follow-up treatment.	through study completion, an average of 3 years
Secondary	quality of life(QoL)	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.	through study completion, an average of 3 years
Secondary	overall survival (OS)	To assess the overall survival (OS)	Assessment overall survival (OS) at 3 years
Secondary	prostate cancer-specific survival (CSS)	To assess the prostate cancer-specific survival	Assessment prostate cancer-specific survival (CSS) at 3 years