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.
Procedure: Salvage treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial|
- Androgen deprivation therapy free survival. [ Time Frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Questionnaire: Short Form (36) Health Survey (SF36)
- Quality of life questionnaire 3 [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ] [ Designated as safety issue: No ]Questionnaire: EORTC QLQ PR25
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558427
|Contact: Piet Ost, MDfirstname.lastname@example.org|
|Ghent University Hospital||Recruiting|
|Contact: Gert De Meerleer, PhD, MD|
|Principal Investigator: Gert De Meerleer, PhD, MD|
|Principal Investigator:||Gert De Meerleer, PhD, MD||Ghent University Hospital|