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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03569241




Registration number
NCT03569241
Ethics application status
Date submitted
14/06/2018
Date registered
26/06/2018

Titles & IDs
Public title
PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases
Scientific title
PEACE V: a Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)
Secondary ID [1] 0 0
EC/2018/0130
Universal Trial Number (UTN)
Trial acronym
STORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Prostate Cancer Metastatic 0 0
Metastatic Cancer 0 0
Oligometastatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - whole pelvic radiotherapy
Treatment: Other - metastasis-directed treatment
Treatment: Surgery - salvage Lymph Node Dissection
Treatment: Drugs - androgen deprivation therapy

Other: MDT + ADT - Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + 6 months androgen deprivation therapy

Experimental: MDT + WPRT + ADT - Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + whole pelvic radiotherapy + 6 months androgen deprivation therapy


Treatment: Other: whole pelvic radiotherapy
addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment

Treatment: Other: metastasis-directed treatment
stereotactic body radiotherapy

Treatment: Surgery: salvage Lymph Node Dissection
metastasis-directed treatment

Treatment: Drugs: androgen deprivation therapy
LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastases-free survival
Timepoint [1] 0 0
2 year
Secondary outcome [1] 0 0
Clinical Progression free survival
Timepoint [1] 0 0
2 year
Secondary outcome [2] 0 0
Biochemical progression-free survival
Timepoint [2] 0 0
2 year
Secondary outcome [3] 0 0
Toxicity: acute toxicity
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Toxicity: late toxicity
Timepoint [4] 0 0
2 year
Secondary outcome [5] 0 0
Patient reported QOL as per EORTC-QLQ C30
Timepoint [5] 0 0
2 year
Secondary outcome [6] 0 0
Patient reported QOL as per EORTC-QLQ PR25
Timepoint [6] 0 0
2 year
Secondary outcome [7] 0 0
Prostate cancer-specific survival
Timepoint [7] 0 0
5 year
Secondary outcome [8] 0 0
Overall survival
Timepoint [8] 0 0
5 year
Secondary outcome [9] 0 0
Time to start of hormonal treatment
Timepoint [9] 0 0
2 year
Secondary outcome [10] 0 0
Time to castration-resistant disease
Timepoint [10] 0 0
5 year
Secondary outcome [11] 0 0
economical evaluation
Timepoint [11] 0 0
2 year
Secondary outcome [12] 0 0
Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery
Timepoint [12] 0 0
3 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
196
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Epworth Healthcare - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussel
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Ghent
Country [6] 0 0
Belgium
State/province [6] 0 0
Kortrijk
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Mouscron
Country [9] 0 0
Italy
State/province [9] 0 0
Milan
Country [10] 0 0
Italy
State/province [10] 0 0
Napoli
Country [11] 0 0
Italy
State/province [11] 0 0
Pavia
Country [12] 0 0
Italy
State/province [12] 0 0
Verona
Country [13] 0 0
Norway
State/province [13] 0 0
Oslo
Country [14] 0 0
Spain
State/province [14] 0 0
Barakaldo
Country [15] 0 0
Spain
State/province [15] 0 0
Bilbao
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Navarro
Country [18] 0 0
Spain
State/province [18] 0 0
Santiago
Country [19] 0 0
Spain
State/province [19] 0 0
Valencia
Country [20] 0 0
Switzerland
State/province [20] 0 0
Basel
Country [21] 0 0
Switzerland
State/province [21] 0 0
Bern
Country [22] 0 0
Switzerland
State/province [22] 0 0
Geneva
Country [23] 0 0
Switzerland
State/province [23] 0 0
Saint Gallen
Country [24] 0 0
Switzerland
State/province [24] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Ghent
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University Hospital, Geneva
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Piet Ost, PhD
Address 0 0
University Hospital, Ghent
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03569241