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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: Surveillance; Procedure: Salvage treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01558427

2012/156

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Active clinical surveillance

Experimental group

Description:

Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.

Treatment:

Procedure: Surveillance

Salvage treatment of metastases

Experimental group

Description:

Surgical or radiotherapy treatment of metastases.

Treatment:

Procedure: Salvage treatment