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PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)

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ClinicalTrials.gov Identifier: NCT03569241
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
University Hospital, Ghent ( University Ghent )

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).


Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Cancer Metastatic Metastatic Cancer Oligometastatic Cancer Radiation: whole pelvic radiotherapy Radiation: metastasis-directed treatment Procedure: salvage Lymph Node Dissection Drug: androgen deprivation therapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
MDT + ADT
Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + 6 months androgen deprivation therapy
Radiation: metastasis-directed treatment
stereotactic body radiotherapy

Procedure: salvage Lymph Node Dissection
metastasis-directed treatment

Drug: androgen deprivation therapy
LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months

Experimental: MDT + WPRT + ADT
Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + whole pelvic radiotherapy + 6 months androgen deprivation therapy
Radiation: whole pelvic radiotherapy
addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment

Radiation: metastasis-directed treatment
stereotactic body radiotherapy

Procedure: salvage Lymph Node Dissection
metastasis-directed treatment

Drug: androgen deprivation therapy
LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months




Primary Outcome Measures :
  1. Metastases-free survival [ Time Frame: 2 year ]
    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


Secondary Outcome Measures :
  1. Clinical Progression free survival [ Time Frame: 2 year ]
    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

  2. Biochemical progression-free survival [ Time Frame: 2 year ]
    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

  3. Toxicity: acute toxicity [ Time Frame: 3 months ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.

  4. Toxicity: late toxicity [ Time Frame: 2 year ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.

  5. quality of life [ Time Frame: 2 year ]

    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


  6. Prostate cancer-specific survival [ Time Frame: 5 year ]
    Cancer specific survival will be read as the time from trial randomization to the date of death due to prostate cancer

  7. Overall survival [ Time Frame: 5 year ]
    Overall survival will be read as the time from trial randomization to the date of death from any cause

  8. Time to start of hormonal treatment [ Time Frame: 2 year ]
    Time to hormonal treatment is defined as the time from trial randomization to start of hormonal treatment

  9. Time to castration-resistant disease [ Time Frame: 5 year ]
    Time to castration resistant disease is defined as the time from trial randomization until castration resistant status

  10. economical evaluation [ Time Frame: 2 year ]
    Assessment of quality-adjusted-life-years with the EuroQol classification system (EQ-5D-5L)

  11. Sensitivity/specificity of PET-CT for the detection of nodal recurrences: limited to patients undergoing surgery [ Time Frame: 3 months ]
    Sensitivity/specificity of PET-CT



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569241


Contacts
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Contact: Piet Ost, PhD 003293323045 piet.ost@ugent.be

Locations
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Australia
Epworth Healthcare Not yet recruiting
Melbourne, Australia
Contact: Shankar Siva, PhD         
Contact: Nathan Lawrentschuk, PhD         
Belgium
GZA Recruiting
Antwerp, Belgium
Contact: Piet Dirix, PhD         
AZ St-Lucas Not yet recruiting
Brugge, Belgium
Contact: Lien Van De Voorde, MD         
Institut Jules Bordet Recruiting
Brussel, Belgium
Contact: François-Xavier Otte, MD         
AZ Maria Middelares Recruiting
Gent, Belgium
Contact: Filip Ameye, MD         
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Piet Ost, PhD         
Principal Investigator: Piet Ost, PhD         
AZ Groeninge Recruiting
Kortrijk, Belgium
Contact: Nick Liefhooghe, MD         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Wouter Everaerts, PhD         
CH Mouscron Recruiting
Mouscron, Belgium
Contact: Sara Junius, MD         
Germany
University Hospital Schleswig-Holstein Not yet recruiting
Lübeck, Germany
Contact: Axel Merseburger, MD, PhD         
Italy
European Institute of Oncology Not yet recruiting
Milan, Italy
Contact: Barbara Jereczek, PhD         
Humanitas Research Hospital Recruiting
Milan, Italy
Contact: Marta Scorsetti, PhD         
Contact: Ciro Franzese, MD         
Ospedale Sacro Cuore-Don Calabria Not yet recruiting
Verona, Italy
Contact: Filippo Alongi, PhD         
Contact: Niccolo Giaj Levra, MD         
Netherlands
UMC Groningen Not yet recruiting
Groningen, Netherlands
Contact: Shafak Al-Uwini, MD         
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Reino Heikkilä, PhD         
Spain
Cruces University Hospital Recruiting
Barakaldo, Spain
Contact: Alfonso Gomez-Iturriaga, MD         
Universitario Quironsalud Recruiting
Madrid, Spain
Contact: Felipe Couñago, PhD         
Hospital Universitari i Politècnic la Fe Not yet recruiting
Valencia, Spain
Contact: Antonio José Conde-Moreno, PhD         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland
Contact: Alexandros Papachristofilou, MD         
Universitätsklinik für Radio-Onkologie Recruiting
Bern, Switzerland
Contact: Mohamed Shelan, MD         
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland
Contact: Thomas Zilli, MD         
Kantonsspital St. Gallen Recruiting
Saint Gallen, Switzerland
Contact: Paul Martin Putora, MD         
UniversitätsSpital Zürich Recruiting
Zürich, Switzerland
Contact: Matthias Guckenberger, PhD         
Sponsors and Collaborators
University Ghent
University Hospital, Geneva
Investigators
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Principal Investigator: Piet Ost, PhD University Hospital, Ghent

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03569241     History of Changes
Other Study ID Numbers: EC/2018/0130
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Ghent ( University Ghent ):
Radiotherapy
metastasis-directed therapy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs