This trial is active, not recruiting.

Condition prostate cancer
Treatments surveillance, salvage treatment
Phase phase 2
Sponsor University Hospital, Ghent
Start date May 2012
End date May 2017
Trial size 54 participants
Trial identifier NCT01558427, 2012/156


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
Active clinical surveillance
Surgical or radiotherapy treatment of metastases.
salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

Primary Outcomes

Androgen deprivation therapy free survival.
time frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.

Secondary Outcomes

Quality of life questionnaire 1.
time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months
Quality of Life questionnaire 2.
time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months
Quality of life questionnaire 3
time frame: At 3, 6, 9, 12, 15, 18, 21, 24 months

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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

Additional Information

Official title Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial
Principal investigator Gert De Meerleer, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.