Trial Title:
Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer
NCT ID:
NCT05707468
Condition:
Oligometastatic Prostate Carcinoma
Conditions: Official terms:
Prostatic Neoplasms
Hormones
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized in a 1:1 ratio between arm A (hormone) and arm B (neoadjuvant
hormone and RT).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ADT combined with abiraterone
Description:
The patients will receive long-term ADT combined with abiraterone.
Arm group label:
A (hormone)
Intervention type:
Radiation
Intervention name:
neoadjuvant hormone and RT
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.
Arm group label:
B (neoadjuvant hormone and RT)
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Contact:
Last name:
Di Gu, PhD
Facility:
Name:
First Affiliated Hospital and Medical College of Soochow University
Address:
City:
Suzhou
Country:
China
Contact:
Last name:
Xiang Ding, PhD
Facility:
Name:
Jiangnan University Medical Center
Address:
City:
Wuxi
Zip:
210009
Country:
China
Contact:
Last name:
Ninghan Feng, PhD
Facility:
Name:
The First Affiliated Hospital of Ningbo University
Address:
City:
Ningbo
Country:
China
Contact:
Last name:
Zejun Yan, PhD
Facility:
Name:
The Second Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200003
Country:
China
Contact:
Last name:
Shancheng Ren, PhD
Phone:
021-81885721
Email:
renshancheng@gmail.com
Facility:
Name:
The First Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Contact:
Last name:
Huojun Zhang, PhD
Phone:
021-31162222
Email:
huojunzh@163.com
Start date:
May 1, 2024
Completion date:
March 1, 2028
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05707468
