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

Phase 3

Recruiting

• Conditions: Oligometastatic Hormone Sensitive Prostate Cancer
• Interventions: Radiation: Stereotactic Body Radiotherapy (SBRT) + Standard of care; Drug: Standard of care

• Registration Number: NCT04115007
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-03
• Study Start: 2020-06-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-06-23
• Study Completion: 2031-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Stereotactic Body Radiotherapy (SBRT) + Standard of care	Standard of care + Stereotactic Body Radiotherapy to oligometastases
Arm B	Standard of care	Standard of care

Primary Outcome Measures

Name	Time	Method
Castration-resistant prostate cancer free survival	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

Name	Time	Method
Overall survival	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	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 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 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 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 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	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)	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	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	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	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	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	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

Trial Locations

Locations (35)

Centre Leon Berard; 🇫🇷 Lyon, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre d'oncologie - Clinique Pasteur; 🇫🇷 Brest, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Institut de cancérologie de Seine et Marne - Clinique de Jossiny; 🇫🇷 Jossigny, France

CHU Martinique; 🇲🇶 Fort-de-France, Martinique

ICO René Gauducheau; 🇫🇷 Nantes, France

Groupe Hospitalier Bretagne Sud; 🇫🇷 Lorient, France

Institut Curie; 🇫🇷 Paris, France

Hôpital Privé du Confluent; 🇫🇷 Nantes, France

CHRU de Brest; 🇫🇷 Brest, France

Centre Azureen de Cancerologie; 🇫🇷 Mougins, France

Centre Oscar Lambret; 🇫🇷 Lille, France

CH Annecy; 🇫🇷 Pringy, France

Institut du Cancer Courlancy; 🇫🇷 Reims, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

CHP Saint Grégoire; 🇫🇷 Saint Gregoire, France

CHU de Rouen - Charles Nicole; 🇫🇷 Rouen, France

IUCT- Oncopole -Institut Claudius Regaud; 🇫🇷 Toulouse, France

HIA Begin; 🇫🇷 Saint-Mandé, France

Institut de cancérologie Strasbourg Europe (ICANS ); 🇫🇷 Strasbourg, France

Institut de cancérologie et d'hématologie universitaire de Saint Etienne; 🇫🇷 Saint-Étienne, France

Institut de Cancerologie Paris Nord; 🇫🇷 Sarcelles, France

Clinique PASTEUR; 🇫🇷 Toulouse, France

Centre Amethyst - Oncologie 78; 🇫🇷 Versailles, France

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Bergonié; 🇫🇷 Bordeaux, France

Centre Amethyst de Creil; 🇫🇷 Creil, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre de radiothérapie Marie Curie de Valence; 🇫🇷 Valence, France

Institut Sainte Catherine; 🇫🇷 Avignon, France