Maximal Tumor Eradication for Oligometastatic Prostate Cancer

NCT06972511 | Recruiting Phase 2 DMC

• 1 other identifier: LY2022-022-B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In China, the incidence of prostate cancer is increasing in recent years, and it has ranked 5th among common male tumors and 1st in urinary tumors. Unlike developed countries in Europe and the United States, in China, because prostate-specific antigen (PSA) screening has not been widely popularized, and early prostate cancer is mostly asymptomatic, about 13%-26% of prostate cancer patients have progressed to metastatic hormone-sensitive prostate cancer (mHSPC) at the time of initial diagnosis. Compared with localized prostate cancer, the 5-year survival rate of mHSPC is only 29.3%, which is prone to symptoms such as bone pain, pathological fracture, hematuria, and dysuria and seriously decrease the survival and quality of life. As a result, it is of great significance to carry out more refined management of mHSPC, explore more scientific treatment options, and delay the time to CRPC, which is of great significance for improving the prognosis and quality of life of patients and reducing medical burden. However, there is still no standard treatment strategy for OMPC patients which need more clinical exploration. Treatment of prostate primary in oligometastatic prostate cancer (OMPC) may improve survival and do not significantly increase complications. Radiotherapy showed excellent therapeutic effects on metastatic lesions, prolonged survival and without increasing significant adverse effects. In 2019, The New England Journal of Medicine reported a TITAN study that combining apatamide with ADT for metastatic hormone-sensitive prostate cancer, which significantly reduced the risk of death (82.4% VS 72.5%, P=0.005), and improved progression-free survival (68.2% VS 47.5, P \<0.001) without increasing adverse effects of treatment. In 2020, Johns Hopkins University published a phase I clinical study of radical treatment of 12 cases of OMPC. Patients were treated with neoadjuvant docetaxel chemotherapy or abiraterone, combined with radical prostatectomy for primary lesions, and stereotactic radiation for bone metastases to achieve the purpose of complete tumor eradication. Preliminary results showed that no additional complications were found except neutropenic fever in two cases. At the same time, the proportion of PSA maintained undetectable in 1,2,3 years was 12 / 12 (100%), 10 / 12 (83%) and 8 / 12 (67%), respectively, showing good treatment results. Since 2014, the applicant has rich research experience in the treatment of oligometastatic prostate cancer and our results showed that systemic therapy combined with local tumor reduction therapy can confer a survival benefit for OMPC patients without a significant increase in complications. This clinical trial aimed to analyze the clinical efficacy and safety of maximal tumor eradication strategy for oligometastatic prostate cancer.

Conditions

Oligometastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to hormone-resistant prostate cancer （TTCRPC）

  5 years

Secondary Outcomes (6)

• overall survival rate

  5 years

• time to clinical imaging progression in both groups

  5 years

• pathological complete response rate

  5 years

• minimum PSA after 6 months of treatment in the two groups

  5 years

• annual EORTC QLQC-30 score after treatment

  5 years

Study Arms (2)

Intervention group A

EXPERIMENTAL

neoadjuvant apatamide plus ADT + radical resection of prostate cancer + extended lymph node dissection + radiotherapy of metastases

Combination Product: neoadjuvant apatamide plus ADT + radical resection of prostate cancer + extended lymph node dissection + radiotherapy of metastases

Control group B

ACTIVE COMPARATOR

Standard ADT treatment

Drug: Standard ADT treatment

Interventions

neoadjuvant apatamide plus ADT + radical resection of prostate cancer + extended lymph node dissection + radiotherapy of metastases COMBINATION_PRODUCT

neoadjuvant apadamide plus ADT: apadamide 240 mg qd po + leuproprolirelin 3.75mg subcutaneous injection once every month. After 4 months of neoadjuvant therapy, radical prostate cancer + extended lymph node dissection, lymph node dissection to the level of bilateral common iliac arteries, and radiotherapy for metastases was completed within 3 months after surgery.Postoperative adjuvant ADT therapy, regular follow-up until progress to hormone-resistant prostate cancer (CRPC) and then change treatment regimen.

Intervention group A

Standard ADT treatment DRUG

leuproprolirelin 3.75mg subcutaneous injection once every month, regular follow-up until progress to hormone-resistant prostate cancer (CRPC) and then change treatment regimen.

Control group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age less than 75 years
• EORTC QLQC-30 score 2
• Life expectancy of 10 years
• Patients with oligometastatic prostate cancer on clinicopathological assessment
• Patients are suitable for radiotherapy and prostatectomy surgery
• Patients agree to participate in the study and sign the informed consent form before enrollment

You may not qualify if:

• Tumor related fracture
• Cannot accept radiotherapy
• Visceral metastasis
• Serious infection
• Thromboembolism history
• Not effectively controlled cardiovascular complications

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi hospital, school of Medicine, Shanghai Jiao Tong University

Shanghai, 200120, China

RECRUITING

MeSH Terms

Interventions

Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

JiaHua Pan, Doctor

CONTACT

+8613916989510; jiahua.pan@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 15, 2025
• Study Start: August 20, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)