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Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Primary Purpose

Oligometastatic Prostate Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ADT combined with abiraterone
neoadjuvant hormone and RT
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oligometastatic Prostate Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without small cell features Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT <4 bone oligometastases, lymph node metastasis below the renal artery level Expected survival time >5 years World Health Organization (WHO) performance status 0-1 Be willing to give written informed consent. Exclusion Criteria: Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc. Patients who have previously undergone transurethral resection or enucleation of the prostate. Patients who have undergone other abdominal surgery within the last 3 months Patients who have visceral metastases Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis Severe or active comorbidities likely to impact the advisability of radiotherapy Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient Patients who have participated in other clinical trials within the last 3 months Patients who refuse to undergo RALP Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical University
  • the First Affiliated Hospital of Guangzhou Medical University
  • Zhongda Hospital Southeast University
  • First Affiliated Hospital and Medical College of Soochow University
  • Shanghai Changzheng Hospital
  • Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A (hormone)

B (neoadjuvant hormone and RT)

Arm Description

The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.

The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.

Outcomes

Primary Outcome Measures

3-year progression-free survival (PFS)
To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).

Secondary Outcome Measures

quality of life (QoL)
quality of life (QoL)
time to castration-resistant prostate cancer (CRPC)
To assess the time to castration-resistant prostate cancer (CRPC)
5-year overall survival (OS)
To assess the overall survival (OS)

Full Information

First Posted
December 15, 2022
Last Updated
April 24, 2023
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05707468
Brief Title
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
Official Title
Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.
Detailed Description
The present study will be conducted as a prospective, open-label, two arms clinical trial. Patients with ≤ 3 de novo oligometastatic PCa, diagnosed on Ga-68 prostate-specific membrane antigen (PSMA) PET/CT, will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT). The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone. The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued. The primary endpoints of the study are progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS). The secondary endpoints include quality of life (QoL), time to CRPC, positive surgical margin (pSM), overall survival (OS), postoperative continence, and toxicities parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligometastatic Prostate Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant hormone and RT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A (hormone)
Arm Type
Active Comparator
Arm Description
The patients in arm A with oligometastatic PCa will receive long-term ADT combined with abiraterone.
Arm Title
B (neoadjuvant hormone and RT)
Arm Type
Experimental
Arm Description
The patients in arm B with oligometastatic PCa will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.
Intervention Type
Drug
Intervention Name(s)
ADT combined with abiraterone
Intervention Description
The patients will receive long-term ADT combined with abiraterone.
Intervention Type
Radiation
Intervention Name(s)
neoadjuvant hormone and RT
Intervention Description
The patients will receive 1 month of naADT, followed by metastasis-directed radiation and abdominal or pelvic radiotherapy. Then, radical prostatectomy will be performed at intervals of 5-15 weeks after radiotherapy, and long-term ADT will be continued.
Primary Outcome Measure Information:
Title
3-year progression-free survival (PFS)
Description
To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).
Time Frame
Assessment progression-free survival (PFS) at 3 years
Secondary Outcome Measure Information:
Title
quality of life (QoL)
Description
quality of life (QoL)
Time Frame
through study completion, an average of 3 years
Title
time to castration-resistant prostate cancer (CRPC)
Description
To assess the time to castration-resistant prostate cancer (CRPC)
Time Frame
through study completion, an average of 3 years
Title
5-year overall survival (OS)
Description
To assess the overall survival (OS)
Time Frame
Assessment overall survival (OS) at 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without small cell features Oligometastatic PCa assessed by Ga-68 prostate-specific membrane antigen (PSMA), PET/CT <4 bone oligometastases, lymph node metastasis below the renal artery level Expected survival time >5 years World Health Organization (WHO) performance status 0-1 Be willing to give written informed consent. Exclusion Criteria: Any previous or ongoing treatment for PCa, including radiotherapy, ADT, chemotherapy, focal treatment, etc. Patients who have previously undergone transurethral resection or enucleation of the prostate. Patients who have undergone other abdominal surgery within the last 3 months Patients who have visceral metastases Patients with a history of long-term anticoagulant use and anti-platelet drug use and who stopped anticoagulant therapy less than 1 week before registration Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis Severe or active comorbidities likely to impact the advisability of radiotherapy Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which, according to the judgement of the investigator, may affect the planned staging, treatment and follow-up or patient compliance or may cause high-risk treatmentrelated complications for the patient Patients who have participated in other clinical trials within the last 3 months Patients who refuse to undergo RALP Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huojun Zhang, PhD
Phone
021-31162222
Email
huojunzh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianzhi Zhao, MD
Phone
021-31162222
Email
zhxzh0007@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Tai, PhD
Facility Name
the First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Gu, PhD
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Xu, PhD
Facility Name
First Affiliated Hospital and Medical College of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhua Huang, PhD
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shancheng Ren, PhD
Phone
021-81885721
Email
renshancheng@gmail.com
Facility Name
Shanghai Changhai Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huojun Zhang, PhD
Phone
021-31162222
Email
huojunzh@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 and specialists in surgerywho are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated withneoadjuvant radiohormonal therapy or androgen deprivation therapy (ADT) combined with abiraterone. 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.

Learn more about this trial

Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

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