Local Treatment With RP for Newly-diagnosed mPCa (LoMP)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Prostatic Neoplasms; Neoplasm Metastasis

Treatments: Procedure: Radical Prostatectomy (RP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02138721

B670201420709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

No local treatment

No Intervention group

Description:

Routine care in metastatic prostate cancer.

Local treatment

Experimental group

Description:

Radical Prostatectomy (RP) + routine care in metastatic prostate cancer.

Treatment:

Procedure: Radical Prostatectomy (RP)