Prostate Cancer
Conditions
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.
Interventions
PROCEDURESurveillance
Active clinical surveillance
PROCEDURESalvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Androgen deprivation therapy free survival. | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life questionnaire 1. | 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. | At 3, 6, 9, 12, 15, 18, 21, 24 months | Questionnaire: Short Form (36) Health Survey (SF36) |
| Quality of life questionnaire 3 | At 3, 6, 9, 12, 15, 18, 21, 24 months | Questionnaire: EORTC QLQ PR25 |
Countries
Belgium
Outcome results
None listed