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

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

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.

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