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NCT Number: NCT06972511

Maximal Tumor Eradication for Oligometastatic Prostate Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

RenJi hospital, school of Medicine, Shanghai Jiao Tong University

Shanghai, 200120, China

Location status: Recruiting

Location contact

JiaHua Pan, Doctor

PRINCIPAL_INVESTIGATOR

Wei Xue, Doctor

PRINCIPAL_INVESTIGATOR

Xiaoguang Shao, Doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to hormone-resistant prostate cancer (TTCRPC)

    Time frame: 5 years

Secondary outcomes

  1. overall survival rate

    Time frame: 5 years

  2. time to clinical imaging progression in both groups

    Time frame: 5 years

  3. pathological complete response rate

    Time frame: 5 years

  4. minimum PSA after 6 months of treatment in the two groups

    Time frame: 5 years

  5. annual EORTC QLQC-30 score after treatment

    Time frame: 5 years

  6. survival rate of disease-free progression

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

JiaHua Pan, Doctor

CONTACT

[email protected]

+8613916989510

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Apatamide Combined With Maximal Tumor Eradication for Oligometastatic Prostate Cancer, A Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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