Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

NCT ID: NCT06335693

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2027-02-28

Brief Summary

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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

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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).

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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adjuvant hypofractionated radiotherapy

Patients after radical prostatectomy with high-risk pathological factors will receive hypofractionated post-prostatectomy radiotherapy in 15 fractions.

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type OTHER

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

Interventions

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Radiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Huo Jun

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huojun Zhang, PhD

Role: STUDY_DIRECTOR

Changhai Hospital

Locations

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The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huojun Zhang, PhD

Role: CONTACT

021-31162222

Xianzhi Zhao, PhD

Role: CONTACT

021-31162222

Facility Contacts

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Huojun Zhang, PhD

Role: primary

021-31162222

Other Identifiers

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CHHHospital

Identifier Type: -

Identifier Source: org_study_id

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