Spots Global Cancer Trial Database for SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy
Official Title: SAKK 08/15 - PROMET - Multicenter, Randomized Phase II Trial of Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy
Study ID: NCT02945813
Conditions
Study Description
Brief Summary: The main objective of the trial is to explore the efficacy of salvage radiotherapy (SRT) plus metformin compared to SRT in the endpoint of time to progression after prostatectomy failure.
Detailed Description: Although the use of salvage radiotherapy (SRT) is the only potentially curative treatment after prostatectomy failure, it has provided suboptimal results over the years. Metformin may represent an effective and inexpensive means to improve SRT outcomes with a favorable therapeutic ratio. Taken pre-clinical and retrospective clinical data together, there is a compelling rationale for conducting a RCT with SRT and metformin. Herein we propose a multicenter, randomized, open-label, proof-of-concept phase II trial with the hypothesis that the addition of metformin to SRT can delay time to progression compared to the standard-of-care SRT. The study has 1:1 randomization and stratification variables include Gleason score, PSA at SRT, surgical margin status and ADT use.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Centre Hospitalier Régional Universitaire (CHRU) Jean Minjoz, Besançon, , France
Clinique Pasteur - Centre finistérien de radiothérapie et d'oncologie, Brest, , France
Centre de lutte contre le cancer Léon Bérard, Lyon, , France
Hôpital Saint-Louis, Paris, , France
CHU de Poitiers - La Miletrie, Poitiers Cedex, , France
Institut de Cancérologie de L'Ouest René Gauducheau, Saint Herblain cedex, , France
Institut de Cancérologie de la Loire Lucien Neuwirth, Saint Priest en Jarez, , France
Clinique Pasteur - Oncorad, Toulouse Cedex 3, , France
Universitätsmedizin Berlin, Berlin, , Germany
Klinikum der Universität München, München, , Germany
Universitätsklinikum Rostock, Rostock, , Germany
Universitätsklinik Tübingen, Tübingen, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Universitätsspital Basel, Basel, , Switzerland
EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
HFR - Hôpital cantonal, Fribourg, , Switzerland
Hôpitaux Universitaires Genève HUG, Geneva, , Switzerland
Clinique de Genolier, Genolier, , Switzerland
Spital Thurgau, Münsterlingen, , Switzerland
Hopital de Sion, Sion, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Klinik Hirslanden, Zurich, , Switzerland
Stadtspital Triemli, Zurich, , Switzerland
UniversitätsSpital Zürich, Zurich, , Switzerland
Contact Details
Name: Daniel M. Aebersold, Prof
Affiliation: Bern University Hospital - Radiation Oncology
Role: STUDY_CHAIR
Name: Alan Dal Pra, MD
Affiliation: Miller School of Medicine, University of Miami
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
