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Trial record 100 of 1439 for:    prostate cancer AND radiation

Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients (PRESTO)

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ClinicalTrials.gov Identifier: NCT04115007
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.

PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.


Condition or disease Intervention/treatment Phase
Oligometastatic Hormone Sensitive Prostate Cancer Radiation: Stereotactic Body Radiotherapy (SBRT) Drug: Standard of care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : January 20, 2023
Estimated Study Completion Date : December 20, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Standard of care + Stereotactic Body Radiotherapy to oligometastases
Radiation: Stereotactic Body Radiotherapy (SBRT)

Definition of standard of care (prior to randomization):

Radiotherapy to the prostate in de novo metastatic patients Long-term Androgen Deprivation Therapy (ADT) with or without intermittent treatment. Additional therapy with abiraterone acetate or docetaxel following tumor board meeting.

With the following radiotherapy modalities:

SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used.

In de novo metastatic patients: Prostate and seminal vesicle external beam radiotherapy using either 74-80 Gy with conventional fractionation (in fractions of 2 Gy) or using a hypofractionated regimen delivering 60 Gy (20 fractions of 3 Gy).


Active Comparator: Arm B
Standard of care
Drug: Standard of care

Definition of standard of care (prior to randomization):

Radiotherapy to the prostate in de novo metastatic patients Long term ADT with or without intermittent treatment. Additional therapy with abiraterone acetate or docetaxel following tumor board meeting.





Primary Outcome Measures :
  1. Castration-resistant prostate cancer free survival [ Time Frame: From randomization to castration resistance or death from any cause, up to 1 year ]
    Castration-resistant prostate cancer free survival, defined as the time from randomization to castration resistance or death from any cause. Castration resistance is defined as either biochemical progression or radiological progression, with serum testosterone being at a castrated level (<50 ng/dL or <1.7 nmol/L).


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From randomization to death from any cause, up to 5 years ]
    The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care

  2. Prostate cancer specific survival [ Time Frame: From randomization to death from prostate cancer, up to 5 years ]
    To evaluate, compared to standard of care, whether SRBT improves survival of patients until death from prostate cancer

  3. Time to castration resistance [ Time Frame: Time from randomization to castration resistance, up to 5 years ]
    The length of time patients leave without resistance to castration treatment, where deaths occurring with no castration resistance (i.e. unrelated to prostate cancer) are censored

  4. Time to next symptomatic skeletal event [ Time Frame: Time from randomization to the first symptomatic skeletal event, up to 5 years ]
    The length of time until manifestation of the first symptomatic skeletal event among the following: symptomatic bone fracture, surgery to bone or use of palliative radiotherapy to bone

  5. Time to next symptomatic skeletal event at the treated metastatic bone sites [ Time Frame: Time from randomization to the first symptomatic skeletal event, 5 years ]
    The length of time until manifestation of the first symptomatic skeletal event, at a site irradiated during the study for patients in the experimental arm, among the following: symptomatic bone fracture, the use of bone surgery, or palliative bone radiotherapy and spinal cord compression

  6. Time to use of intermittent hormonal therapy [ Time Frame: Time from randomization to the use of intermittent androgen deprivation therapy, up to 5 years ]
    The length of time patients receive continuous androgen deprivation therapy before the switch to the intermittent androgen deprivation therapy

  7. Duration of intermittent hormonal therapy [ Time Frame: From the end of continuous therapy to the end of intermittent therapy, up to 5 years ]
    The length of time patients receive intermittent androgen deprivation therapy

  8. Time to secondary treatments (local or systemic) [ Time Frame: From randomization to initiation of secondary treatment, up to 5 years ]
    The interval between the randomization and the initiation of the first treatment after disease progression: systemic chemotherapy, second line hormonal therapy, bone directed treatment (bisphosphonate or denosumab), or the use an antalgic palliative bone treatment (interventional radiology or radiotherapy)

  9. Acute and late toxicity of stereotactic radiotherapy of oligometastases: Adverse events [ Time Frame: Throughout study completion, up to 5 years ]
    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.

  10. Severity of pain during treatment [ Time Frame: At baseline before radiotherapy, week 6, and at every follow-up (every three months for the first three years then every 6 months for the last two years after randomization), up to 5 years ]

    The Brief Pain Inventory (BPI) questionnaire rapidly assesses the severity of pain and its impact on functioning. This self-report questionnaire includes:

    • A body schema
    • The maximum pain, lowest pain, usual pain within the last 15 days (Numerical Numeric rating scales (NRS) 0 to 10
    • Description of current analgesic treatment
    • An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).

  11. The 3-level version of EQ-5D (EQ-5D-3L) questionnaire [ Time Frame: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years) ]

    This self-reported questionnaire that assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS).

    The EQ-5D-3L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 3 levels (1 = "no problems", 2 = "some problems", and 3 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (Best imaginable health state) to 100 (Worst imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.


  12. Expanded Prostate Cancer Index Composite (EPIC) short form [ Time Frame: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years) ]
    This self-reported questionnaire, designed to evaluate patient function and bother after prostate cancer treatment, contains 26 item divided in 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life.

  13. Cost-effectiveness analysis of the proposed therapeutic strategy [ Time Frame: At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, castration resistance (up to 5 years) ]
    To evaluate the economic cost of the SBRT treatment as compared to the treatment without radiotherapy in terms of cost assessments, incremental cost-effectiveness ratio and quality of life adjusted life years



Information from the National Library of Medicine

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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 adenocarcinoma of the prostate (any T stage, Gleason score or prostate-specific antigen (PSA) level)
  • Defined as M1 based on the presence of at least one bone metastasis
  • Diagnostic workup including functional imaging (F- or C-Choline-PET/CT, Prostate Specific Membrane Antigen (PSMA) PET/CT or whole body MRI) and TAP CT done before the start of hormonal therapy
  • With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone lesion with or without nodal metastases. Are counted as a separate metastasis each bone lesion and each node located outside the true pelvis with a small diameter of 1cm or greater or with univocal abnormal function imaging (PET Scan hyperfixation or hypersignal in whole body MRI)
  • Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings
  • Age ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤2
  • Suitable for long term anti androgen therapy
  • Patient not suitable for docetaxel or abiraterone can be included
  • Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization
  • Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment
  • Patient must have received the information sheet and signed the consent form
  • Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
  • Patient must be affiliated to the social security system.

Exclusion Criteria:

  • Patient with more than 5 metastatic sites
  • Patient with metastatic sites other than bone or lymph nodes (lung, brain, or liver metastases)
  • Metastases not amenable to stereotactic body radiotherapy by multidisciplinary meeting (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment)
  • Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit
  • Castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT
  • Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years
  • Contra-indication to MRI (needed for spinal SBRT)
  • Persons deprived of their liberty or under protective custody or guardianship;
  • Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
  • Participation in another therapeutic trial within 30 days prior to 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): NCT04115007


Contacts
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Contact: Sandra PELISSIER +33 1 44 23 55 68 s-pelissier@unicancer.fr

Sponsors and Collaborators
UNICANCER

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT04115007     History of Changes
Other Study ID Numbers: UC-0160/1716
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Hypersensitivity
Genital Diseases, Male
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs