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SNCTP000002947 | NCT03569241 | BASEC2018-00164

PEACE V : Etude randomisée de phase II pour le traitement de rattrapage du cancer de la prostate en récidive ganglionnaire oligométastatique (STORM)

Data source: BASEC (Imported from 14.04.2021), WHO (Imported from 11.04.2021)
Changed: 03.03.2021
Disease category: Prostate Cancer

Brief description of trial (Data source: BASEC)

Le but de cette étude est de comparer en termes d’effets bénéfiques et indésirables une irradiation pelvienne (du bas-ventre) associée à un curage ganglionnaire ou à une radiothérapie focalisée, versus une approche par chirurgie ou une irradiation seule.

Health conditions investigated (Data source: BASEC)

Cancer de la prostate en récidive ganglionnaire limitée au pelvis

Health conditions (Data source: WHO)

Prostate Cancer;Prostate Cancer Metastatic;Metastatic Cancer;Oligometastatic Cancer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Pour cette étude, les participants seront divisés en deux groupes :
- le groupe 1 (souvent appelé “bras A”), sera traité soit par curage ganglionnaire, soit par radiothérapie focale limitée aux ganglions suspects.
- le groupe 2 (souvent appelé “bras B”), sera traité soit par curage ganglionnaire, soit par radiothérapie focale limitée aux ganglions suspects mais ces traitements seront suivis d’une radiothérapie pelvienne.

Les patients seront affectés au hasard à l’un des 2 groupes.

Interventions (Data source: WHO)

Radiation: whole pelvic radiotherapy;Radiation: metastasis-directed treatment;Procedure: salvage Lymph Node Dissection;Drug: androgen deprivation therapy

Criteria for participation in trial (Data source: BASEC)

- adénocarcinome de la prostate
- âgé de plus de 18 ans
- capable de signer le consentement

Exclusion criteria (Data source: BASEC)

- métastases osseuses ou viscérales
- métastases des ganglions para-aortique
- irradiation précédente du pelvis ou des ganglions para-aortique

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Histologically proven initial diagnosis of adenocarcinoma of the prostate

- Biochemical relapse of prostate cancer following radical local prostate treatment
(radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed
adjuvant/ salvage radiotherapy) according to the EAU guidelines 2016.

- Following radical prostatectomy, patients with a biochemical relapse are eligible in
case a nodal relapse is detected in the pelvis even in the absence of prior
postoperative prostate bed radiotherapy (adjuvant or salvage).

- In case of a suspected local recurrence following primary radiotherapy, a biopsy
should confirm local recurrence and patients with a confirmed local recurrence are
eligible in case they also undergo a local salvage therapy. If imaging rules out local
relapse, patients are eligible.

- Nodal relapse in the pelvis on choline, PSMA or FACBC PET-CT with a maximum of 3
positive nodal lymph nodes. The upper limit of the pelvis is defined as the aortic
bifurcation.

- WHO performance state 0-1

- Age >18 years

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule; those
conditions should be discussed with the patient before registration in the trial

- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

- Bone or visceral metastases

- Para-aortic lymph node metastases (above the aortic bifurcation)

- Local relapse in the prostate gland or prostate bed not suitable for a curative
treatment

- Previous irradiation of the pelvic and or para-aortic nodes

- Serum testosterone level <50ng/dl or 1.7 nmol/L at time of randomization

- Symptomatic metastases

- Lymph node metastases in previously irradiated areas resulting in dose constraint
violation

- Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)

- Contraindications to androgen deprivation therapy

- PSA rise while on active treatment with (LHRH-agonist, LHRH-antagonist, anti-androgen,
estrogen

- Previous treatment with cytotoxic agent for PCa

- Treatment during the past month with products known to influence PSA levels (e.g.
fluconazole, finasteride, corticosteroids,…)

- Other active malignancy, except non-melanoma skin cancer or other malignancies with a
documented disease-free survival for a minimum of 3 years before randomization.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03569241

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03569241

Further information on trial

Date trial registered

14.06.2018

Incorporation of the first participant

27.04.2018

Recruitment status

Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Metastases-free survival

Secundary end point (Data source: WHO)

Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery;economical evaluation;Time to castration-resistant disease;Time to start of hormonal treatment;Overall survival;Prostate cancer-specific survival;Patient reported QOL as per EORTC-QLQ PR25;Patient reported QOL as per EORTC-QLQ C30;Toxicity: late toxicity;Toxicity: acute toxicity;Biochemical progression-free survival;Clinical Progression free survival

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Bern, Geneva, St. Gallen, Zurich

Countries (Data source: WHO)

Australia, Belgium, Germany, Italy, Netherlands, Norway, Spain, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. Thomas Zilli
+41 22 37 27 132
thomas.zilli@hcuge.ch

Contact for general information (Data source: WHO)

Piet Ost, PhD
University Hospital, Ghent
003293323015
piet.ost@ugent.be

Contact for scientific information (Data source: WHO)

Piet Ost, PhD
University Hospital, Ghent
003293323015
piet.ost@ugent.be

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University Ghent

Additional sponsors (Data source: WHO)

University Hospital, Geneva

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Commission Cantonale d’éthique de la recherche Genève (CCER)

Date of authorisation by the ethics committee

07.08.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-00164

Secondary ID (Data source: WHO)

EC/2018/0130