Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial (LoMP II)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer Metastatic

Treatments: Radiation: Whole pelvis radiotherapy; Procedure: radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03655886

BC-01880

Details and patient eligibility

About

According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.

Enrollment: 43 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male ≥18y
• Histologically proven PC
• Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy) or PSMA PET-CT
• ECOG 0-1 (2 if related to local PC symptoms)
• Eligible for local treatment
• Written informed consent and able and willing to comply with protocol requirements

Exclusion criteria

• Previous systemic treatment for PC except ADT started within 3 months before randomization
• Previous radiotherapy to the pelvis interfering with prostate irradiation
• Previous surgery in the pelvis interfering with radical prostatectomy
• Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
• Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
• Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
• Psychological disorder intervening with understanding the information or the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Radical prostatectomy

Experimental group

Treatment:

Procedure: radical prostatectomy

Radiotherapy

Experimental group

Treatment:

Radiation: Whole pelvis radiotherapy