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NCT Number: NCT03655886

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

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.

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Key information

Conditions

Prostate Cancer Metastatic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp University Hospital, Edegem, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radical prostatectomy

Procedure

can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon

Whole pelvis radiotherapy

Radiation

radiation of prostate bed and pelvis

Primary outcomes

  1. Feasibility of randomization between both treatment arms as assessed by the randomized proportion

    Time frame: 48 months

    In this trial we want to assess whether it is feasible to randomize patients into both treatment arms. All patients eligible for inclusion will be reported. The eventual proportion of randomized patients will be evaluated. Reasons for exclusion will be monitored.

Secondary outcomes

  1. Radiographic progression-free survival

    Time frame: 48 months

    Calculated starting from date of randomization to radiographic progression or death from any cause whichever occurred first

  2. Clinical progression-free survival

    Time frame: 48 months

    Calculated starting from date of randomization to the date of radiographic progression, symptoms, initiation of new treatment, or death, whichever occurred first.

  3. Quality of life (QLQ-C30 + QLQ-PR25)

    Time frame: 48 months

    Evaluation of quality of life will be done using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire, extended by the QLQ-PR25.

  4. Acute and late toxicity due to local treatment

    Time frame: 48 months

    Early complications after radical prosatatectomy will be evaluated using the Clavien-Dindo classification for surgical complications.

    Acute and late toxicity after radiotherapy will be evaluated using the Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). This outcome will be assessed descriptively, as a direct comparison between the two toxicity classifications would be inappropriate.

Other outcomes

  1. Castration-resistant free survival

    Time frame: 48 months

    Calculated starting from date of randomization until castration-resistant disease development, as defined by the European Association of Urology (EAU) guidelines

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: LoMP II

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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