Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Oligometastatic Prostate Carcinoma Clinical Trial

Official title:

Safety and Efficacy Study of Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer: a Multi-center Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05707468
• Other study ID #: Changhai Hospital PCa
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: February 2024
• Source: Changhai Hospital
• Contact: Huojun Zhang, PhD
• Phone: 021-31162222
• Email: huojunzh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 1, 2028
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oligometastatic Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Drug:
• ADT combined with abiraterone
The patients will receive long-term ADT combined with abiraterone.

Radiation:
• neoadjuvant hormone and RT
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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang
China	The First Affiliated Hospital of Naval Medical University	Shanghai
China	The Second Affiliated Hospital of Naval Medical University	Shanghai
China	First Affiliated Hospital and Medical College of Soochow University	Suzhou	Jiangsu
China	Jiangnan University Medical Center	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year progression-free survival (PFS)	To assess progression-free survival (PFS) including biochemical recurrence-free survival (bPFS), and radiological progression-free survival (RPFS).	Assessment progression-free survival (PFS) at 3 years
Secondary	quality of life (QoL)	quality of life (QoL)	through study completion, an average of 3 years
Secondary	time to castration-resistant prostate cancer (CRPC)	To assess the time to castration-resistant prostate cancer (CRPC)	through study completion, an average of 3 years
Secondary	5-year overall survival (OS)	To assess the overall survival (OS)	Assessment overall survival (OS) at 5 years