Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01558427|
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Ghent.
Recruitment status was: Active, not recruiting
First Posted : March 20, 2012
Last Update Posted : June 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Surveillance Procedure: Salvage treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Active clinical surveillance
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
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.
- 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.
- 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)
- Quality of Life questionnaire 2. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]Questionnaire: Short Form (36) Health Survey (SF36)
- Quality of life questionnaire 3 [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]Questionnaire: EORTC QLQ PR25
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
|Ghent University Hospital|
|Principal Investigator:||Gert De Meerleer, PhD, MD||University Hospital, Ghent|