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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01558427
Recruitment Status : Active, not recruiting
First Posted : March 20, 2012
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Surveillance Procedure: Salvage treatment Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial
Study Start Date : May 2012
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Active clinical surveillance
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
Procedure: Surveillance
Active clinical surveillance
Experimental: Salvage treatment of metastases
Surgical or radiotherapy treatment of metastases.
Procedure: Salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558427


Locations
Belgium
Ghent University Hospital
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Gert De Meerleer, PhD, MD University Hospital, Ghent