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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 )

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE April 27, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03569241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • 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
  • 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
  • Toxicity: acute toxicity [ Time Frame: 3 months ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
  • Toxicity: late toxicity [ Time Frame: 2 year ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
  • 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
  • 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
  • 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
  • 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
  • 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
  • economical evaluation [ Time Frame: 2 year ]
    Assessment of quality-adjusted-life-years with the EuroQol classification system (EQ-5D-5L)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • 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
  • 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
  • Toxicity: acute toxicity [ Time Frame: 3 months ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
  • Toxicity: late toxicity [ Time Frame: 2 year ]
    Radiotherapy toxicity will be assessed according to NCI CTCAE v4.0.
  • 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 PR-25
  • 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
  • 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
  • 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
  • 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
  • economical evaluation [ Time Frame: 2 year ]
    Assessment of quality-adjusted-life-years with the EuroQol classification system (EQ-5D-5L)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PEACE V: Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases
Official Title  ICMJE PEACE V: A Randomized Phase II Trial for the Salvage Treatment of OligoRecurrent Nodal Prostate Cancer Metastases (STORM)
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).

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Prostate Cancer Metastatic
  • Metastatic Cancer
  • Oligometastatic Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • MDT + ADT
    Metastasis-directed therapy (salvage lymph node dissection OR stereotactic body radiotherapy) + 6 months androgen deprivation therapy
    Interventions:
    • Radiation: metastasis-directed treatment
    • Procedure: salvage Lymph Node Dissection
    • Drug: 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
    Interventions:
    • Radiation: whole pelvic radiotherapy
    • Radiation: metastasis-directed treatment
    • Procedure: salvage Lymph Node Dissection
    • Drug: androgen deprivation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Piet Ost, PhD 003293323045 piet.ost@ugent.be
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569241
Other Study ID Numbers  ICMJE EC/2018/0130
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Ghent ( University Ghent )
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE University Hospital, Geneva
Investigators  ICMJE
Principal Investigator: Piet Ost, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP