Clinical trial NCT05707468: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oligometastatic Prostate Carcinoma
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: 3-year progression-free survival (PFS)
timeFrame: Assessment progression-free survival (PFS) at 3 years
Secondary outcomes:
measure: quality of life (QoL)
timeFrame: through study completion, an average of 3 years
measure: time to castration-resistant prostate cancer (CRPC)
timeFrame: through study completion, an average of 3 years
measure: 5-year overall survival (OS)
timeFrame: Assessment overall survival (OS) at 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Suzhou
country: China
facility: First Affiliated Hospital and Medical College of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Jiangnan University Medical Center
state: Jiangsu
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Shanghai
country: China
facility: The Second Affiliated Hospital of Naval Medical University
city: Shanghai
country: China
facility: The First Affiliated Hospital of Naval Medical University
Study officials:
References: