Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer

NCT06198387 | Not Yet Recruiting

• 1 other identifier: Changhai Hosp omPCa
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The existing large prospective study demonstrates the benefits of primary radiotherapy in patients with low-volume oligo-metastatic prostate cancer (OMPC), and there is also more evidence of the benefits of local metastasis-directed therapy (MDT) for metastatic lesions. But there is no results from prospective study to demonstrate the efficacy of radiotherapy for prostate and oligo-metastases. Therefore, the aim of the protocol is to illustrate the efficacy of radiotherapy for prostate and oligo-metastatic lesions in patients with de novo OMPC.

Conditions

Oligo-metastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• progression-free survival 2 (PFS2)

  To assess the duration from the reinitiation of endocrine therapy until the identification of disease progression again.

  through study completion, an average of 3 years

Secondary Outcomes (3)

• ADT free survival

  through study completion, an average of 3 years

• self-assessment of quality of life (QoL) and patient satisfaction

  through study completion, an average of 3 years

• 5-year overall survival (OS)

  Assessment overall survival (OS) at 5 years

Study Arms (1)

hormone and RT

EXPERIMENTAL

Patients with de novo oligo-metastatic prostate cancer will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy.

Radiation: hormone and RT; Drug: ADT combined with abiraterone

Interventions

hormone and RT RADIATION

The patients will receive a two-year course of androgen deprivation therapy (ADT) in combination with abiraterone, along with synchronous metastasis-directed radiation and prostate radiotherapy(RT).

hormone and RT

ADT combined with abiraterone DRUG

The patients will receive a two-year course of ADT combined with abiraterone.

hormone and RT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or over at the time of registration
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;
• Histologically confirmed prostate adenocarcinoma via prostate biopsy;
• Assessment conducted via single-photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), and Ga-68 prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography(PET/CT), revealing oligo-metastasis (involving \< 4 metastatic lesions in non-pelvic lymph nodes and bones) with or without pelvic lymph node involvement;
• Expected survival duration \>2 years.
• The willingness of patients to voluntarily accept the experimental research protocol after being informed of existing treatment options.

You may not qualify if:

• Any previous or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, focal treatment, etc.
• Pathology indicating small-cell or neuroendocrine tumor components;
• Patients with visceral metastases, or ≥4 metastases;
• Patients with concurrent malignancies or those in an acute infection period or severe infection state; patients positive for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), and/or syphilis (Treponema pallidum)
• Severe or active systemic comorbidities that, in the investigator's judgment, might interfere with the treatment, evaluation, and compliance of this trial, including severe conditions affecting respiratory, circulatory, nervous, mental, digestive, endocrine, immune, urological, and other systems;
• Individuals with contraindications related to radiation therapy may present heightened risks of treatment-related complications.
• Patients participating in other clinical trials;
• Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Xu B, Zhao X, Feng Z, Li J, Liang Y, Zhang W, Chen L, Shen X, Qu M, Gao X, Zhang H. Protocol for Evaluating the Efficacy and Safety of Radiotherapy for Prostate and Oligometastatic Lesions in Patients With Low-Burden Sensitive Oligometastatic Prostate Cancer: An Open, Exploratory Pilot Clinical Trial. Cancer Control. 2024 Jan-Dec;31:10732748241274595. doi: 10.1177/10732748241274595.

  PMID: 39180187 DERIVED

MeSH Terms

Interventions

Hormones; abiraterone

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Zhang Huojun, PHD

CONTACT

021-31162222; huojunzh@163.com

Bichun Xu, MD

CONTACT

021-31162222; bchunxu@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: Professor

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 5 years after the publication of the study.
• Access Criteria: Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of oligo-metastatic prostate cancer treated with radiation combined with drug or androgen deprivation therapy (ADT) combined with abiraterone. Detailed study protocol should be emailed along with the request of the data. The investigators may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)