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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Surveillance
Salvage treatment
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active clinical surveillance

Salvage treatment of metastases

Arm Description

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

Surgical or radiotherapy treatment of metastases.

Outcomes

Primary Outcome Measures

Androgen deprivation therapy free survival.
Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.

Secondary Outcome Measures

Quality of life questionnaire 1.
Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)
Quality of Life questionnaire 2.
Questionnaire: Short Form (36) Health Survey (SF36)
Quality of life questionnaire 3
Questionnaire: EORTC QLQ PR25

Full Information

First Posted
March 12, 2012
Last Updated
September 1, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01558427
Brief Title
Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer
Official Title
Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active clinical surveillance
Arm Type
Experimental
Arm Description
Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
Arm Title
Salvage treatment of metastases
Arm Type
Experimental
Arm Description
Surgical or radiotherapy treatment of metastases.
Intervention Type
Procedure
Intervention Name(s)
Surveillance
Intervention Description
Active clinical surveillance
Intervention Type
Procedure
Intervention Name(s)
Salvage treatment
Intervention Description
Surgical removal of metastases, or stereotactic body radiotherapy of metastases.
Primary Outcome Measure Information:
Title
Androgen deprivation therapy free survival.
Description
Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.
Time Frame
From date of randomization until androgen deprivation therapy is started, assessed up to 2 years.
Secondary Outcome Measure Information:
Title
Quality of life questionnaire 1.
Description
Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)
Time Frame
At 3, 6, 9, 12, 15, 18, 21, 24 months
Title
Quality of Life questionnaire 2.
Description
Questionnaire: Short Form (36) Health Survey (SF36)
Time Frame
At 3, 6, 9, 12, 15, 18, 21, 24 months
Title
Quality of life questionnaire 3
Description
Questionnaire: EORTC QLQ PR25
Time Frame
At 3, 6, 9, 12, 15, 18, 21, 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert De Meerleer, PhD, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
36001857
Citation
Deek MP, Van der Eecken K, Sutera P, Deek RA, Fonteyne V, Mendes AA, Decaestecker K, Kiess AP, Lumen N, Phillips R, De Bruycker A, Mishra M, Rana Z, Molitoris J, Lambert B, Delrue L, Wang H, Lowe K, Verbeke S, Van Dorpe J, Bultijnck R, Villeirs G, De Man K, Ameye F, Song DY, DeWeese T, Paller CJ, Feng FY, Wyatt A, Pienta KJ, Diehn M, Bentzen SM, Joniau S, Vanhaverbeke F, De Meerleer G, Antonarakis ES, Lotan TL, Berlin A, Siva S, Ost P, Tran PT. Long-Term Outcomes and Genetic Predictors of Response to Metastasis-Directed Therapy Versus Observation in Oligometastatic Prostate Cancer: Analysis of STOMP and ORIOLE Trials. J Clin Oncol. 2022 Oct 10;40(29):3377-3382. doi: 10.1200/JCO.22.00644. Epub 2022 Aug 24.
Results Reference
derived
PubMed Identifier
29240541
Citation
Ost P, Reynders D, Decaestecker K, Fonteyne V, Lumen N, De Bruycker A, Lambert B, Delrue L, Bultijnck R, Claeys T, Goetghebeur E, Villeirs G, De Man K, Ameye F, Billiet I, Joniau S, Vanhaverbeke F, De Meerleer G. Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial. J Clin Oncol. 2018 Feb 10;36(5):446-453. doi: 10.1200/JCO.2017.75.4853. Epub 2017 Dec 14.
Results Reference
derived
PubMed Identifier
25963190
Citation
Ploussard G, Almeras C, Briganti A, Giannarini G, Hennequin C, Ost P, Renard-Penna R, Salin A, Lebret T, Villers A, Soulie M, de la Taille A, Flamand V. Management of Node Only Recurrence after Primary Local Treatment for Prostate Cancer: A Systematic Review of the Literature. J Urol. 2015 Oct;194(4):983-8. doi: 10.1016/j.juro.2015.04.103. Epub 2015 May 9.
Results Reference
derived
PubMed Identifier
25223986
Citation
Decaestecker K, De Meerleer G, Ameye F, Fonteyne V, Lambert B, Joniau S, Delrue L, Billiet I, Duthoy W, Junius S, Huysse W, Lumen N, Ost P. Surveillance or metastasis-directed Therapy for OligoMetastatic Prostate cancer recurrence (STOMP): study protocol for a randomized phase II trial. BMC Cancer. 2014 Sep 15;14:671. doi: 10.1186/1471-2407-14-671.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
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Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

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