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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT01558427
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
60
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surveillance
  • Procedure: Salvage treatment
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial
Study Start Date :
May 1, 2012
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Quality of Life questionnaire 2. [At 3, 6, 9, 12, 15, 18, 21, 24 months]

    Questionnaire: Short Form (36) Health Survey (SF36)

  3. Quality of life questionnaire 3 [At 3, 6, 9, 12, 15, 18, 21, 24 months]

    Questionnaire: EORTC QLQ PR25

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Ghent University Hospital Ghent Belgium

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Gert De Meerleer, PhD, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01558427
Other Study ID Numbers:
  • 2012/156
First Posted:
Mar 20, 2012
Last Update Posted:
Jun 2, 2016
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Jun 2, 2016