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OpenTrials
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NCT Number: NCT01558427

Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. However, in patients with limited metastatic load, the time to progression might be. Subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (ADT) for several months to years. As an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of ADT even longer. The current trial hypothesizes that ADT might be deferred longer following salvage treatment as compared to active surveillance.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven diagnosis of prostate cancer (PCa)
  • Biochemical relapse of PCa following radical local prostate treatment
  • N1 and M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
  • World Health Organization (WHO) performance state 0-1
  • Exclusion of local relapse
  • Age >=18 years old
  • Signed informed consent

Exclusion criteria

  • Serum testosterone level <50ng/ml
  • Symptomatic metastases
  • PSA rise while on active treatment with luteinizing hormone-releasing hormone (LHRH)-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen
  • Previous treatment with cytotoxic agent for PCa
  • Treatment during the past month with products known to influence Prostate Specific Antigen (PSA) levels (e.g. fluconazole, finasteride, corticosteroids,…)
  • Disorder precluding understanding of trial information or informed consent

Treatment and study plan

Surveillance

Procedure

Active clinical surveillance

Salvage treatment

Procedure

Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

Primary outcomes

  1. Androgen deprivation therapy free survival.

    Time frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.

    Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.

Secondary outcomes

  1. Quality of life questionnaire 1.

    Time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months

    Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)

  2. Quality of Life questionnaire 2.

    Time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months

    Questionnaire: Short Form (36) Health Survey (SF36)

  3. Quality of life questionnaire 3

    Time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months

    Questionnaire: EORTC QLQ PR25

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

Important dates

Study start
2012
Primary completion
2018
Study completion
2023
First posted
Mar 20, 2012
Registry last updated
Sep 5, 2023

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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