Clinical trial NCT03655886: Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial
Official title: Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation As a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer Metastatic
Keywords: metastatic
prostate cancer
local
cytoreductive
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of randomization between both treatment arms as assessed by the randomized proportion
timeFrame: 48 months
Secondary outcomes:
measure: Radiographic progression-free survival
timeFrame: 48 months
measure: Clinical progression-free survival
timeFrame: 48 months
measure: Quality of life (QLQ-C30 + QLQ-PR25)
timeFrame: 48 months
measure: Acute and late toxicity due to local treatment
timeFrame: 48 months
Other outcomes:
measure: Castration-resistant free survival
timeFrame: 48 months
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
city: Ghent
country: Belgium
facility: AZ Jan Palfijn
state: East Flanders
city: Leuven
country: Belgium
facility: Leuven University Hospital
state: Flemish Brabant
city: Bruges
country: Belgium
facility: AZ Sint-Jan
state: West Flanders
city: Ghent
country: Belgium
facility: AZ Maria Middelares
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References: