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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558427
• Other study ID #: 2012/156
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2012
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Surveillance
Active clinical surveillance
• Salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of Life questionnaire 2.	Questionnaire: Short Form (36) Health Survey (SF36)	At 3, 6, 9, 12, 15, 18, 21, 24 months
Secondary	Quality of life questionnaire 3	Questionnaire: EORTC QLQ PR25	At 3, 6, 9, 12, 15, 18, 21, 24 months

External Links

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