NCT01558427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

6 years

First QC Date

March 12, 2012

Last Update Submit

September 1, 2023

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Quality of life questionnaire 1.

    At 3, 6, 9, 12, 15, 18, 21, 24 months

  • Quality of Life questionnaire 2.

    At 3, 6, 9, 12, 15, 18, 21, 24 months

  • Quality of life questionnaire 3

    At 3, 6, 9, 12, 15, 18, 21, 24 months

Study Arms (2)

Active clinical surveillance

EXPERIMENTAL

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

Procedure: Surveillance

Salvage treatment of metastases

EXPERIMENTAL

Surgical or radiotherapy treatment of metastases.

Procedure: Salvage treatment

Interventions

SurveillancePROCEDURE

Active clinical surveillance

Active clinical surveillance
Salvage treatmentPROCEDURE

Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

Salvage treatment of metastases

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age \>=18 years old
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 36001857DERIVED

  • 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.

    PMID: 29240541DERIVED

  • 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.

    PMID: 25963190DERIVED

  • 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.

    PMID: 25223986DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gert De Meerleer, PhD, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 20, 2012

Study Start

August 1, 2012

Primary Completion

August 15, 2018

Study Completion

August 15, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

BE(1)