Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01558427|
Recruitment Status : 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
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|