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

NCT ID: NCT06198387

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2028-09-01

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.

Detailed Description

This study involves a single-center, limited-sample, single-arm exploration of radiotherapy for prostate and oligo-metastatic lesions in patients diagnosed with low-volume, hormone-sensitive OMPC. Eligible participants undergo thorough assessments and treatment involving endocrine therapy alongside radiation targeting metastatic lesions and the pelvic region. All patients received radiation therapy for both the primary and metastatic lesions combined endocrine therapy. Endocrine therapy with an antiandrogen (bicalutamide,for 4 weeks) androgen deprivation therapy combined with novel hormonal agents (acetate abiraterone), which will be continued for 2 years. The primary objective is to evaluate progression-free survival-2 (PFS-2), while secondary endpoints include ADT free survival, quality of life (QoL), overall survival, time to castration-resistant prostate cancer (CRPC), radiation-related complications and endocrine therapy related adverse events.

Conditions

Oligo-metastatic Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hormone and RT

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.

Group Type: EXPERIMENTAL

hormone and RT

Intervention Type: 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).

ADT combined with abiraterone

Intervention Type: DRUG

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

Interventions

hormone and RT

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).

Intervention Type: RADIATION

ADT combined with abiraterone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Huo Jun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Zhang Huojun, PHD

Role: CONTACT

huojunzh@163.com

021-31162222

Bichun Xu, MD

Role: CONTACT

bchunxu@163.com

021-31162222

Facility Contacts

Zhang Huojun

Role: primary

huojunzh@163.com

021-31162222

References

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.

Reference Type: DERIVED

PMID: 39180187 (View on PubMed)

Other Identifiers

Changhai Hosp omPCa

Identifier Type: -

Identifier Source: org_study_id