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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03569241
Ethics application status
Date submitted
14/06/2018
Date registered
26/06/2018
Date last updated
30/07/2019

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 - Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by choline, FACBC or PSMA PET-CT or death due to any cause
Timepoint [1] 0 0
2 year
Secondary outcome [1] 0 0
Clinical Progression free survival - Clinical Progression-free survival is defined as time between randomization and the appearance of a new recurrence (any N1 or M1) as suggested by PET-CT, symptoms related to progressive PCa, or death due to any cause
Timepoint [1] 0 0
2 year
Secondary outcome [2] 0 0
Biochemical progression-free survival - For patients who had previous RP at initial diagnosis, a biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/ml with a confirmatory rise at least 2 weeks later. For patients who had previous RT to the prostate at initial diagnosis, a biochemical recurrence is defined as the nadir + 2ng/ml (Phoenix definition). Non-responders are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA
Timepoint [2] 0 0
2 year
Secondary outcome [3] 0 0
Toxicity: acute toxicity - Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Toxicity: late toxicity - Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
Timepoint [4] 0 0
2 year
Secondary outcome [5] 0 0
quality of life - QOL will be assessed by the summary score of the scale for bowel symptoms included in the EORTC QLQ.
Scale name: PRBOW. Higher values represent a worse outcome. Total range of total score: 0-100. The items (ranging from 1 to 4 on a Likert-scale) were converted into values ranging from 0 to 100. A score of 100 can be interpreted as maximal bowel symptoms.
PR-25
Timepoint [5] 0 0
2 year
Secondary outcome [6] 0 0
Prostate cancer-specific survival - Cancer specific survival will be read as the time from trial randomization to the date of death due to prostate cancer
Timepoint [6] 0 0
5 year
Secondary outcome [7] 0 0
Overall survival - Overall survival will be read as the time from trial randomization to the date of death from any cause
Timepoint [7] 0 0
5 year
Secondary outcome [8] 0 0
Time to start of hormonal treatment - Time to hormonal treatment is defined as the time from trial randomization to start of hormonal treatment
Timepoint [8] 0 0
2 year
Secondary outcome [9] 0 0
Time to castration-resistant disease - Time to castration resistant disease is defined as the time from trial randomization until castration resistant status
Timepoint [9] 0 0
5 year
Secondary outcome [10] 0 0
economical evaluation - Assessment of quality-adjusted-life-years with the EuroQol classification system (EQ-5D-5L)
Timepoint [10] 0 0
2 year
Secondary outcome [11] 0 0
Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery - Sensitivity/specificity of PET-CT
Timepoint [11] 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Germany
State/province [9] 0 0
Lübeck
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
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
Netherlands
State/province [13] 0 0
Groningen
Country [14] 0 0
Norway
State/province [14] 0 0
Oslo
Country [15] 0 0
Spain
State/province [15] 0 0
Barakaldo
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Santiago
Country [18] 0 0
Spain
State/province [18] 0 0
Valencia
Country [19] 0 0
Switzerland
State/province [19] 0 0
Basel
Country [20] 0 0
Switzerland
State/province [20] 0 0
Bern
Country [21] 0 0
Switzerland
State/province [21] 0 0
Geneva
Country [22] 0 0
Switzerland
State/province [22] 0 0
Saint Gallen
Country [23] 0 0
Switzerland
State/province [23] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
University 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
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).
Trial website
https://clinicaltrials.gov/show/NCT03569241
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
Piet Ost, PhD
Address 0 0
Country 0 0
Phone 0 0
003293323045
Fax 0 0
Email 0 0
piet.ost@ugent.be
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03569241