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

Not Applicable

Not yet recruiting

• Conditions: Oligo-metastatic Prostate Carcinoma
• Interventions: Radiation: hormone and RT; Drug: ADT combined with abiraterone

• Registration Number: NCT06198387
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hormone and RT	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.
hormone and RT	ADT combined with abiraterone	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.

Primary Outcome Measures

Name	Time	Method
progression-free survival 2 (PFS2)	through study completion, an average of 3 years	To assess the duration from the reinitiation of endocrine therapy until the identification of disease progression again.

Secondary Outcome Measures

Name	Time	Method
ADT free survival	through study completion, an average of 3 years	To assess the timeframe between the completion of the initial ADT treatment and the onset of the subsequent ADT treatment.
self-assessment of quality of life (QoL) and patient satisfaction	through study completion, an average of 3 years	To evaluate utilizing QoL questionnaires.In the EQ-5D descriptive system five dimensions are assessed: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Patients are asked to rate each dimension on a scale ranging from 'no problems'(1) to 'unable to/ extreme problems'(5).The VAS is a vertical scale ranging from 0 to 100 where 0 indicates worst imaginable health and 100 indicates best imaginable health.
5-year overall survival (OS)	Assessment overall survival (OS) at 5 years	To assess the duration from enrollment until death from any cause or the last follow-up.

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China