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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
Date last updated
1/07/2024

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 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/study/NCT03569241
Trial related presentations / publications
Huck C, Achard V, Zilli T. Surgical Treatments of Benign Prostatic Hyperplasia and Prostate Cancer Stereotactic Radiotherapy: Impact on Long-Term Genitourinary Toxicity. Clin Oncol (R Coll Radiol). 2022 Sep;34(9):e392-e399. doi: 10.1016/j.clon.2022.05.021. Epub 2022 Jun 15.
Corkum MT, Achard V, Morton G, Zilli T. Ultrahypofractionated Radiotherapy for Localised Prostate Cancer: How Far Can We Go? Clin Oncol (R Coll Radiol). 2022 May;34(5):340-349. doi: 10.1016/j.clon.2021.12.006. Epub 2021 Dec 25.
Zilli T, Dirix P, Heikkila R, Liefhooghe N, Siva S, Gomez-Iturriaga A, Everaerts W, Otte F, Shelan M, Mercier C, Achard V, Thon K, Stellamans K, Moon D, Conde-Moreno A, Papachristofilou A, Scorsetti M, Guckenberger M, Ameye F, Zapatero A, Van De Voorde L, Lopez Campos F, Counago F, Jaccard M, Spiessens A, Semac I, Vanhoutte F, Goetghebeur E, Reynders D, Ost P. The Multicenter, Randomized, Phase 2 PEACE V-STORM Trial: Defining the Best Salvage Treatment for Oligorecurrent Nodal Prostate Cancer Metastases. Eur Urol Focus. 2021 Mar;7(2):241-244. doi: 10.1016/j.euf.2020.12.010. Epub 2020 Dec 29.
De Bruycker A, Spiessens A, Dirix P, Koutsouvelis N, Semac I, Liefhooghe N, Gomez-Iturriaga A, Everaerts W, Otte F, Papachristofilou A, Scorsetti M, Shelan M, Siva S, Ameye F, Guckenberger M, Heikkila R, Putora PM, Zapatero A, Conde-Moreno A, Counago F, Vanhoutte F, Goetghebeur E, Reynders D, Zilli T, Ost P. PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial. BMC Cancer. 2020 May 12;20(1):406. doi: 10.1186/s12885-020-06911-4.
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



Summary Results

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