Clinical trial NCT02138721: Local Treatment With RP for Newly-diagnosed mPCa
Official title: Local Treatment With Radical Prostatectomy (RP) for Newly-diagnosed Metastatic Prostate Cancer (mPCa).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Neoplasm Metastasis
Keywords: Metastatic Prostate Cancer
Prostatectomy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Castration Refractory Prostate Cancer Progression-Free Survival
timeFrame: up to 10 years
measure: Time to first Disease Related Event
timeFrame: up to 10 years
Secondary outcomes:
measure: Overall Survival
timeFrame: at year 1 - 2 - 5
measure: Prostate Cancer Specific Survival
timeFrame: at year 1 - 2 - 5
measure: Quality of Life
timeFrame: at month 6 - 12
measure: Time to Androgen Deprivation Therapy start
timeFrame: up to 10 years, estimated to occur within 24 months
Other outcomes:
measure: Cytoreductive effect of local treatment in metastatic disease lesions [%]
timeFrame: at month 3 - 6
measure: Cost-effectiveness of local treatment arm versus no local treatment arm
timeFrame: analysis after trial ending, estimated in 10-15 years
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Ghent
country: Belgium
facility: University Hospital, Ghent
city: Heusden-Zolder
country: Belgium
facility: Sint-Fransiskusziekenhuis
city: Vilvoorde
country: Belgium
facility: AZ Jan Portaels
Study officials:
affiliation: University Hospital, Ghent
name: Nicolaas Lumen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poelaert F, Verbaeys C, Rappe B, Kimpe B, Billiet I, Plancke H, Decaestecker K, Fonteyne V, Buelens S, Lumen N. Cytoreductive Prostatectomy for Metastatic Prostate Cancer: First Lessons Learned From the Multicentric Prospective Local Treatment of Metastatic Prostate Cancer (LoMP) Trial. Urology. 2017 Aug;106:146-152. doi: 10.1016/j.urology.2017.02.051. Epub 2017 Apr 20.