Neoadjuvant Radiohormonal Therapy for Oligometastatic Prostate Cancer

Naval Military Medical University

Status: Not yet enrolling

Conditions: Oligometastatic Prostate Carcinoma

Treatments: Radiation: neoadjuvant hormone and RT; Drug: ADT combined with abiraterone

Study type: Interventional

Funder types: Other

Identifiers

NCT05707468

Changhai Hospital PCa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A (hormone)

Active Comparator group

Description:

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

Treatment:

Drug: ADT combined with abiraterone

B (neoadjuvant hormone and RT)

Experimental group

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.

Treatment:

Radiation: neoadjuvant hormone and RT