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

• ClinicalTrials.gov Identifier: NCT01558427
• Recruitment Status: Completed
• First Posted: March 20, 2012
• Last Update Posted: September 5, 2023
• Sponsor: University Hospital, Ghent
• Information provided by (Responsible Party): University Hospital, Ghent

Tracking Information

• First Submitted Date: March 12, 2012
• First Posted Date: March 20, 2012
• Last Update Posted Date: September 5, 2023
• Actual Study Start Date: August 1, 2012
• Actual Primary Completion Date: August 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2012)

Androgen deprivation therapy free survival. [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 16, 2012)

• Quality of life questionnaire 1. [ Time Frame: 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)
• Quality of Life questionnaire 2. [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]
  Questionnaire: Short Form (36) Health Survey (SF36)
• Quality of life questionnaire 3 [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24 months ]
  Questionnaire: EORTC QLQ PR25

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

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

Study Arms

• Experimental: Active clinical surveillance
  Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.
  Intervention: Procedure: Surveillance
• Experimental: Salvage treatment of metastases
  Surgical or radiotherapy treatment of metastases.
  Intervention: Procedure: Salvage treatment

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2022): 62
• Original Estimated Enrollment (submitted: March 16, 2012): 54
• Actual Study Completion Date: August 15, 2023
• Actual Primary Completion Date: August 15, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01558427
• Other Study ID Numbers: 2012/156
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Ghent
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Ghent
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Ghent
• Verification Date: September 2023