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Spots Global Cancer Trial Database for PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

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Trial Identification

Brief Title: PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases

Official Title: PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)

Study ID: NCT03569241

Study Description

Brief Summary: A proportion of prostate cancer (PCa) patients develop relapse following curative local treatment. Regional nodal recurrence is an emerging clinical situation since the introduction of new molecular imaging methods in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of progression, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (salvage lymph node dissection, sLND or stereotactic body radiotherapy, SBRT) or MDT plus whole pelvis radiotherapy (WPRT: 45 Gy in 25 fractions).

Detailed Description: A proportion of prostate cancer (PCa) patients develop a local, regional (N1) or distant (M1) relapse following curative local treatment. For both local and distant relapses, different treatment recommendations are made in the guidelines (EAU guidelines 2016). However, the entity regional nodal recurrence is not mentioned in the guidelines but is an emerging clinical situation since the introduction of choline and more recently PSMA PET-CT in the restaging of recurrent prostate cancer. More specifically, a subgroup of these patients is being diagnosed with a recurrence confined to the regional lymph nodes and limited in number (oligorecurrence) using choline or PSMA PET-CT. As there are no specific treatment recommendations for these type of patients, different treatment approaches are currently used, mostly focusing on local ablative treatments using radiotherapy or surgery. These treatments are coined metastasisdirected therapy (MDT). MDT in combination with or without temporary ADT could delay the subsequent risk of metastases, and even cure limited regional nodal recurrences. Consequently, lifelong palliative ADT, with its toxicity and excess in non-cancer mortality might be postponed. The proposed trial randomizes patients with oligorecurrent nodal prostate cancer following primary PCa treatment to either metastasis-directed therapy (MDT) (sLND or SBRT) or MDT plus WPRT. In the recurrent PCa setting, 2 recent trials have suggested a progression-free and even survival benefit of adding temporary ADT to local salvage prostate bed radiotherapy. Consequently, this positive effect might also be applicable for regional recurrences. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms. This trial will improve our insights in the pattern of recurrence following these treatment modalities with the expectation that WPRT will reduce the number of nodal relapses, improving metastasis-free survival and postponing the need for palliative systemic treatments while maintaining quality-of-life. The current phase II trial will try to establish a golden standard in the treatment of oligorecurrent nodal PCa.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Epworth Healthcare, Melbourne, , Australia

GZA, Antwerp, , Belgium

AZ St-Jan Brugge, Brugge, , Belgium

AZ St-Lucas, Brugge, , Belgium

Institut Jules Bordet, Brussel, , Belgium

AZ Maria Middelares, Gent, , Belgium

University Hospital Ghent, Ghent, , Belgium

AZ Groeninge, Kortrijk, , Belgium

UZ Leuven, Leuven, , Belgium

CH Mouscron, Mouscron, , Belgium

Humanitas Research Hospital, Milan, , Italy

Vita-Salute San Raffaele University, Milan, , Italy

Istituto Nazionale Tumori IRCCS, Napoli, , Italy

Fondazione IRCCS Policlinico S. Matteo, Pavia, , Italy

Ospedale Sacro Cuore-Don Calabria, Verona, , Italy

Oslo University Hospital, Oslo, , Norway

Cruces University Hospital, Barakaldo, , Spain

Clínica Universitaria IMQ, Bilbao, , Spain

Hospital Ramón y Cajal, Madrid, , Spain

Hospital Universitario La Princesa, Madrid, , Spain

Universitario Quironsalud, Madrid, , Spain

Hospitalario de Navarra, Navarro, , Spain

Hospital Clínico de Santiago, Santiago, , Spain

Hospital Universitari i Politècnic la Fe, Valencia, , Spain

Universitätsspital Basel, Basel, , Switzerland

Universitätsklinik für Radio-Onkologie, Bern, , Switzerland

Hôpitaux Universitaires de Genève, Geneva, , Switzerland

Kantonsspital St. Gallen, Saint Gallen, , Switzerland

UniversitätsSpital Zürich, Zürich, , Switzerland

Contact Details

Name: Piet Ost, PhD

Affiliation: University Hospital, Ghent

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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