Adjuvant Hypofractionated Radiotherapy for Prostate Cancer

NCT06335693 | Recruiting DMC

• 1 other identifier: CHHHospital
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• progression-free survival (PFS)

  Assessment progression-free survival (PFS) at 3 years

• medical expenses

  through study completion, an average of 3 years

• quality of life(QoL)

  through study completion, an average of 3 years

• overall survival (OS)

  Assessment overall survival (OS) at 3 years

• prostate cancer-specific survival (CSS)

  Assessment prostate cancer-specific survival (CSS) at 3 years

Study Arms (1)

adjuvant hypofractionated radiotherapy

EXPERIMENTAL

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

Other: Radiotherapy

Interventions

Radiotherapy OTHER

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

adjuvant hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Huojun Zhang, PhD

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Huojun Zhang, PhD

CONTACT

021-31162222; huojunzh@163.com

Xianzhi Zhao, PhD

CONTACT

021-31162222; zhxzh0007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 28, 2024
• Study Start: March 28, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 3 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists and specialists in surgery who are interested in examining the efficacy and toxicity of hypofractionated radiotherapy following radical prostatectomy. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)