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

January 8, 2024 updated by: Zhang Huo Jun, Changhai Hospital

Efficacy and Safety of Radiotherapy for Prostate and Oligo-metastatic Lesions in Patients With Low-burden Oligo-metastatic Prostate Cancer: An Open, Exploratory Pilot Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: 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).
Drug: ADT combined with abiraterone
The patients will receive a two-year course of ADT combined with abiraterone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival 2 (PFS2)
Time Frame: 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.
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADT free survival
Time Frame: 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.
through study completion, an average of 3 years
self-assessment of quality of life (QoL) and patient satisfaction
Time Frame: 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.
through study completion, an average of 3 years
5-year overall survival (OS)
Time Frame: Assessment overall survival (OS) at 5 years
To assess the duration from enrollment until death from any cause or the last follow-up.
Assessment overall survival (OS) at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai Hosp omPCa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

IPD Sharing Time Frame

Within 5 years after the publication of the study.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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