Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

Sponsor
Fudan University
Study ID
NCT05212857
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Leuprolide acetate — DRUG
    Given subcutaneously or as an injection
  • Goserelin acetate — DRUG
    Given subcutaneously or as an injection
  • Triptorelin acetate — DRUG
    Given subcutaneously or as an injection
  • Degarelix acetate — DRUG
    Given subcutaneously or as an injection
  • Abiraterone acetate — DRUG
    Given orally
  • Apalutamide — DRUG
    Given orally
  • Enzalutamide — DRUG
    Given orally
  • Local treatment for primary lesion — PROCEDURE
    Radical prostatectomy to remove prostate primary lesion
  • Radiotherapy for primary lesion — RADIATION
    Radical radiotherapy for primary lesion
  • Radiotherapy for metastatic lesion — RADIATION
    Stereotactic body radiation therapy or proton and heavy ion radiation therapy is preferred, which could treat all the lesions at once or treat different lesions in stages.

Study Details

Oligo-metastatic prostate cancer (OMPCa) is considered as an intermediated state between localized and poly-metastatic disease. Various retrospective studies and prospective clinical trials are carrying out to validate whether patients with OMPCa could benefit from local treatment for both primary and metastatic lesions. The investigators here to conduct a unique clinical trial which OMPCa patients were confirmed by conventional imaging, and received a long-term enhanced systemic therapy accompanied by tumor-directed therapy.

Key Dates

Start date
Apr 30, 2022
Status verified
Mar 2022
Primary completion
Feb 29, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: systemic treatment combined with radical treatment and radiotherapy
    All recruited participants would receive long-term and unified systemic treatment. Systemic treatment is defined as chemical castration plus new-generation anti-androgen therapy. For the primary lesion: The preferred local treatment for primary lesion is radical prostatectomy. Patients who refuse surgery or whose tumors cannot be surgically resected after 3 months' systemic treatment could receive radical radiotherapy. For the metastatic lesion: Radiotherapy for metastatic lesions would be performed between 4 weeks and 24 weeks after the local treatment for primary lesion. Stereotactic body radiation therapy (SBRT) is preferred, which could treat all the detected lesions at once or in stages.

Primary Outcome Measure

Two years' radiographic progression-free survival (rPFS) [ Time Frame: 2 years ]

Central Contacts

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