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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active clinical surveillance | Experimental | Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging. |
|
| Salvage treatment of metastases | Experimental | Surgical or radiotherapy treatment of metastases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveillance | Procedure | Active clinical surveillance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire 1. | Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30) | At 3, 6, 9, 12, 15, 18, 21, 24 months |
| Quality of Life questionnaire 2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gert De Meerleer, PhD, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36001857 | Derived | 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. | |
| 29240541 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Not provided
| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Salvage treatment |
| Procedure |
Surgical removal of metastases, or stereotactic body radiotherapy of metastases. |
|
Questionnaire: Short Form (36) Health Survey (SF36)
| At 3, 6, 9, 12, 15, 18, 21, 24 months |
| Quality of life questionnaire 3 | Questionnaire: EORTC QLQ PR25 | At 3, 6, 9, 12, 15, 18, 21, 24 months |
| Derived |
| 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. |
| 25963190 | Derived | 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. |
| 25223986 | Derived | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |