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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Surveillance
* Procedure: Salvage treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active clinical surveillance<br>Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging. | Procedure: Surveillance<br>* Active clinical surveillance<br>|
| Experimental: Salvage treatment of metastases<br>Surgical or radiotherapy treatment of metastases. | Procedure: Salvage treatment<br>* Surgical removal of metastases, or stereotactic body radiotherapy of metastases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgen deprivation therapy free survival. | Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started. | From date of randomization until androgen deprivation therapy is started, assessed up to 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire 1. | Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30) | At 3, 6, 9, 12, 15, 18, 21, 24 months | 
| Quality of Life questionnaire 2. | Questionnaire: Short Form (36) Health Survey (SF36) | At 3, 6, 9, 12, 15, 18, 21, 24 months | 
| Quality of life questionnaire 3 | Questionnaire: EORTC QLQ PR25 | At 3, 6, 9, 12, 15, 18, 21, 24 months |