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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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.
- 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]).
- 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.
- 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.
- 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
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
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