NCT02138721

Local Treatment With RP for Newly-diagnosed mPCa

Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

Detailed description

Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study. Study Groups: After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done. Follow-up: Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care. Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established. Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following: * symptoms related to metastatic lesion(s) * Prostate Specific Antigen (PSA) \> 50ng/ml and doubling time (PSA-DT) \< 6 months (starting 3 months after inclusion at earliest) The estimated number of patients to be included in the local treatment arm is 40.

Conditions

• Prostatic Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	Radical Prostatectomy (RP)	Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.

Timeline

• Start date: 2018-06-28
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2014-05-15
• Last updated: 2023-12-20

Locations

5 sites across 1 country: Belgium