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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Surveillance; Procedure: Salvage treatment

• Registration Number: NCT01558427
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-20
• Study Start: 2012-08-01
• Primary Completion: 2018-08-15
• Study Completion: 2023-08-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active clinical surveillance	Surveillance	Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
Salvage treatment of metastases	Salvage treatment	Surgical or radiotherapy treatment of metastases.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of life questionnaire 3	At 3, 6, 9, 12, 15, 18, 21, 24 months	Questionnaire: EORTC QLQ PR25
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)

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium