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Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer (PLATON)

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ClinicalTrials.gov Identifier: NCT03784755
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
TerSera Therapeutics LLC
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Brief Summary:
The purpose of this study is to compare the effects of ablative therapy (radiation or surgery) to all sites of disease combined with standard treatments on prostate cancer, compared to the standard or usual treatments used to treat this disease.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Radiation: Ablative Radiation Therapy Other: Standard of care Not Applicable

Detailed Description:

The standard or usual treatment for this disease is systemic therapy, which includes androgen deprivation therapy (ADT) with or without chemotherapy or hormone therapy. Additionally, for some patients with specific disease features, standard treatment may also include ablative treatment (radiation or surgery) of the prostate gland if this was not completed prior to enrolling into this study.

Ablative Therapy is a procedure used to destroy cancer cells and tissue. In this study Stereotactic Body Radiation Therapy (SBRT) or surgery will be used to destroy prostate cancer metastases. It is not clear if ablative therapy (SBRT or surgery) to all sites of disease used in combination with standard systemic therapy can offer better results than standard treatment alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1 (standard of care)

Standard systemic therapy

+ Ablative therapy to untreated prostate primary for patients with low volume metastatic disease burden

Other: Standard of care
Patients continue to receive their current planned systemic therapy at the discretion of the treating physician

Experimental: Arm 2 (standard systemic therapy + ablative therapy))

Local Ablative therapy to all sites of disease (including untreated prostate primary)

+ Standard systemic therapy

Radiation: Ablative Radiation Therapy
Undergo stereotactic radiotherapy and/or surgery to all sites of disease (oligometastases and primary prostate if previously untreated).
Other Names:
  • SBRT
  • Stereotactic External Beam Irradiation
  • Stereotactic Radiation Therapy
  • Stereotactic Radiotherapy

Other: Standard of care
Patients continue to receive their current planned systemic therapy at the discretion of the treating physician




Primary Outcome Measures :
  1. Failure-free Survival [ Time Frame: 6 years ]
    defined as the time from randomization to the time of the first occurrence.


Secondary Outcome Measures :
  1. Radiographic Progression-free Survival [ Time Frame: 6 years ]
    the comparison of these outcomes between the two treatment arms will be tested by the log-rank test

  2. Incidence of new metastases as first event [ Time Frame: 6 years ]
    the comparison of these outcomes between the two treatment arms will be tested by the log-rank test

  3. Overall Survival [ Time Frame: 6 years ]
    the comparison of these outcomes between the two treatment arms will be tested by the log-rank test

  4. Ablative treatment related adverse events (>/= grade 3) using CTCAE v5.0 [ Time Frame: 6 years ]
  5. Quality of Life measured by EORTC QLQ-C30 [ Time Frame: 6 years ]
    It consists of both multi-item scales and single item measures, including five functioning domains, a global quality of life domain, three symptom domains and six single items. For each domain or single item measure a linear transformation will be applied to standardize the raw score to range between 0 and 100

  6. Quality of Life measured by Bone Metastases module (BM22) [ Time Frame: 6 years ]
    The BM22 has 22 questions consisting of the 4 subscales (painful sites (PS) and pain characteristics (PC) on the symptom scale and functional interference (FI) and psychosocial aspects (PA) on the functional scale). Modules, relevant subscales will also be linear transformed to standardize the raw score to range between 0 and 100 in accordance with the EORTC scoring manuals.

  7. Quality of Life measured by prostate (PR25) questionnaire module [ Time Frame: 6 years ]
    has 25 questions in four domains (urinary, bowel, sexual, and hormonal). Modules, relevant subscales will also be linear transformed to standardize the raw score to range between 0 and 100 in accordance with the EORTC scoring manuals.

  8. Economic analysis measured by EQ-5D-5L [ Time Frame: 6 years ]
    The robustness of the model results will be assessed using one-way and multi-way sensitivity analyses. Major drivers of medical care costs, namely hospitalization, chemotherapy and survival, will be varied ± 20%, to examine the impact on the base-case incremental cost effectiveness ratios (ICERs). Bootstrapping and the development of a cost-effectiveness acceptability curve will also be conducted.

  9. Economic analysis by determining an incremental cost-effectiveness ratio reported as a difference in cost per FFS-year between the 2 arms [ Time Frame: 6 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologic diagnosis/confirmation of prostate adenocarcinoma and no evidence of small cell cancer.
  • Stage IV at presentation or relapse after curative intent therapy, classification per AJCC 8th edition: M1 disease with ≤ 5 metastases
  • ≤ 3 metastases in any non-bone organ system
  • Zoladex must commence within 12 weeks prior to randomization or within 12 weeks after randomization.
  • Radiology (CT/MRI chest/abdomen/pelvis) within 42 days of randomization
  • Bone scan within 42 days of randomization
  • All tumours (Primary prostate and metastases) must be amenable to local ablative therapy (radiation and/or surgery).
  • Age ≥ 18
  • ECOG performance 0-1
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and economics questionnaires in either English or French
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be medically suitable for study treatments as assessed by the appropriate specialties: medical, radiation, and surgical
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • In accordance with CCTG policy, ablative therapy to metastases is to begin within 6 weeks after patient randomization
  • Men of childbearing potential must have agreed to use a highly effective contraceptive method to prevent pregnancy while on study
  • Patient must consent to provision of, and Investigator must confirm location of and commit to obtain a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative studies described in the protocol may be conducted. Where tissue exists but local centre regulations prohibit submission of blocks of tumour tissue, the approval of the CCTG must be sought prior to randomization of the first patient to allow cores (two 2 mm cores of tumour from the block) and slides (20 x 5 micron thick unstained slides) of representative tumour tissue to be substituted
  • Patient must consent to provision of samples of whole blood (for cfDNA) in order that the specific correlative studies described in the protocol may be conducted.

Exclusion Criteria:

  • Prior treatment with ADT in the neoadjuvant or adjuvant setting, unless treatment was discontinued ≥ 12 months prior to randomization AND total duration of treatment was ≤ 36 months (including expiry of last depot injection).
  • Previously diagnosed recurrent/metastatic disease which has been already treated with any systemic therapy or radiotherapy
  • Castration resistant prostate cancer, defined as rising PSA (per PCWG3) or radiographic progression in the setting of castrate levels of serum testosterone (< 1.7 nmol/L).
  • Patients who present with de novo stage IV disease with pelvic lymphadenopathy as their only site of metastases (N1 M0), where the primary prostate has never been treated with curative intent prostate surgery or radiotherapy in the past.
  • Inability to treat all sites of disease with local ablative therapy
  • Patients with parenchymal brain metastases

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): NCT03784755


Contacts
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Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

Locations
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Canada, British Columbia
BCCA - Vancouver Island Cancer Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Abraham S. Alexander    250 519-5575 ext 77094      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Bashir Bashir    204 578-2208      
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Adam Gladwish    705 728-9090      
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Kimmen Quan         
Trillium Health Partners - Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Andrew Chiang    905 813-1100 ext 5115      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Morgan    613 737-7700 ext 70206      
Algoma District Cancer Program Not yet recruiting
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Contact: Mohammad Rassouli    705 759-3434 ext 4450      
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Ryan Carlson    705 522-6237 ext 2451      
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Patrick C.F. Cheung    416 480-6165      
Canada, Quebec
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: M. Tamim Niazi    514 340-8288      
Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: William Foster    418 691-5264      
Sponsors and Collaborators
Canadian Cancer Trials Group
TerSera Therapeutics LLC
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Study Chair: Patrick CF Cheung Odette Cancer Centre, Sunnybrook Health Science Centre, Toronto, ON Canada
Study Chair: M. Tamim Niazi The Jewish General Hospital, Montreal, QC Canada
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03784755    
Other Study ID Numbers: PR20
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Canadian Cancer Trials Group:
Oligometastatic Hormone
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases