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

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01558427
First received: March 12, 2012
Last updated: September 6, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Procedure: Surveillance
Procedure: Salvage treatment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Androgen deprivation therapy free survival. [ Time Frame: From date of randomization until androgen deprivation therapy is started, assessed up to 2 years. ] [ Designated as safety issue: No ]
    Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.


Secondary Outcome Measures:
  • Quality of life questionnaire 1. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ] [ Designated as safety issue: No ]
    Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)

  • Quality of Life questionnaire 2. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ] [ Designated as safety issue: No ]
    Questionnaire: Short Form (36) Health Survey (SF36)

  • Quality of life questionnaire 3 [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ] [ Designated as safety issue: No ]
    Questionnaire: EORTC QLQ PR25


Estimated Enrollment: 54
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active clinical surveillance
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
 Procedure: Surveillance
Active clinical surveillance
Experimental: Salvage treatment of metastases
Surgical or radiotherapy treatment of metastases.
 Procedure: Salvage treatment
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558427

Contacts
Contact: Piet Ost, MD piet.ost@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium
Contact: Gert De Meerleer, PhD, MD            
Principal Investigator: Gert De Meerleer, PhD, MD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Gert De Meerleer, PhD, MD Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01558427     History of Changes
Other Study ID Numbers: 2012/156
Study First Received: March 12, 2012
Last Updated: September 6, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013