Local Treatment With RP for Newly-diagnosed mPCa

Not Applicable

Recruiting

• Conditions: Prostatic Neoplasms; Neoplasm Metastasis
• Interventions: Procedure: Radical Prostatectomy (RP)

• Registration Number: NCT02138721
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Study Start: 2018-06-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Diagnosis of prostate adenocarcinoma, confirmed by histology
• Newly diagnosis of metastatic disease (stage TanyNanyM+)
• Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
• Written informed consent, male ≥18yo
• Willing and expected to comply with study protocol and follow-up schedule
• Multidisciplinary Oncologic Consultation (MOC) approval

Exclusion Criteria

• Previous local or systemic treatment for prostate cancer
• Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
• Symptoms clearly related to metastatic lesions
• Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local treatment	Radical Prostatectomy (RP)	Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.

Primary Outcome Measures

Name	Time	Method
Time to first Disease Related Event	up to 10 years	From date of inclusion until the date of any event related to local disease progression (eg ureter obstruction, bladder outlet obstruction), any Skeletal Related Event (SRE) or any event related to metastasis (eg lymphedema). \[months\]
Castration Refractory Prostate Cancer Progression-Free Survival	up to 10 years	From date of inclusion until the date of Castration Refractory Prostate Cancer (CRPC) defined according to European Association of Urology (EAU) guidelines, or date of death from any cause, whichever came first, assessed up to 10 years. \[months\]

Secondary Outcome Measures

Name	Time	Method
Quality of Life	at month 6 - 12	Evaluated by the EuroQoL 5 Dimensions 5 Levels Questionnaire
Time to Androgen Deprivation Therapy start	up to 10 years, estimated to occur within 24 months	From date of inclusion until the date of start of Androgen Deprivation Therapy (ADT) (criteria described in protocol) \[months\]
Overall Survival	at year 1 - 2 - 5	From date of inclusion until the date of death from any cause, assessed up to 10 years. \[months\]
Prostate Cancer Specific Survival	at year 1 - 2 - 5	From date of inclusion until the date of death due to prostate cancer, assessed up to 10 years. \[months\]

Trial Locations

Locations (5)

AZ Jan Portaels; 🇧🇪 Vilvoorde, Belgium

University Hospital, Ghent; 🇧🇪 Ghent, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Sint-Fransiskusziekenhuis; 🇧🇪 Heusden-Zolder, Belgium