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Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis (RADIOSA)

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ClinicalTrials.gov Identifier: NCT03940235
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jereczek Barbara, MD, European Institute of Oncology

Brief Summary:

A randomized phase II clinical trial (RADIOSA trial: Radioablation with or without Androgen DeprIvation therapy in metachronous prostate cancer OligometaStAsis).

The aim is to compare time to progression between the two study arms: SBRT only or SBRT and hormonotherapy (ADT). The primary objective is to compare the progression-free survival (PFS) defined as the absence of new metastatic lesions (local, regional or distant) between the two arms. The secondary endpoints include the comparison of overall survival (OS), biochemical progression-free survival (BPFS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease and QoL between the two arms; the development of a dedicated biobanking (collection of plasma and serum) for further biological investigation of predictive/diagnostic factors for personalized treatment; the preliminary evaluation of prognostic biomarkers; the correlation between imaging-derived parameters and treatment outcome.


Condition or disease Intervention/treatment Phase
Oligometastatic Prostate Cancer Drug: Androgen deprivation therapy (ADT) Radiation: SBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Stereotactic body Radiotherapy (SBRT) only
ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.
Radiation: SBRT
SBRT to all radiological documented lesions (bone or lymphnodes)

Active Comparator: Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)
ARM 2: salvage SBRT (as described for ARM 1) + 6-month ADT (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist). ADT should start within one week before the start of SBRT.
Drug: Androgen deprivation therapy (ADT)
SBRT + ADT

Radiation: SBRT
SBRT to all radiological documented lesions (bone or lymphnodes)




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: up 3 months from the end of the treatment up to radiological progression within 3 years ]
    Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up the end of SBRT until death for cancer or other causes up to 3 years ]
    From the end of RT treatment to the time of clinical progression or mortality from specific disease cause

  2. Biochemical progression-free survival (BPFS) [ Time Frame: up 3 months from the end of the treatment up to 3 years ]
    Biochemical progression is defined according to the EAU guidelines [18], namely a rising PSA level >0.2 ng/ml following radical prostatectomy and >2 ng/ml above the nadir after radiation therapy.

  3. Numbers of patients who experienced acute and late toxicity [ Time Frame: Up to 1 months after treatment completion and then up to 3 years ]
    Toxicity will be assessed according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.3



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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:

  • Histologically proven initial diagnosis of adenocarcinoma of the prostate;
  • Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 [18] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa;
  • Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions;
  • Serum testosterone level >50 ng/dl at the time of randomization (castration sensitive PCa)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Age ≥18 years;
  • Written informed consent signed

Exclusion criteria

  • Serious concomitant comorbidities or contraindication to SBRT and/or ADT;
  • Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies;
  • No ability to complete questionnaires about QoL;
  • Presence of mental diseases that cannot ensure valid informed consent;

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): NCT03940235


Contacts
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Contact: Barbara A Jereczek-Fossa, Prof +39 0257489037 barbara.jereczek@ieo.it
Contact: Giulia marvaso, MD +39 0294372696 giuliamarvaso@gmail.com

Locations
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Italy
Istituto Europeo di Oncologia IRCCS Recruiting
Milan, MI - Milano, Italy, 20135
Contact: Barbara A Jereczek-Fossa, Prof    +39 0257489037    barbara.jereczek@ieo.it   
Sponsors and Collaborators
European Institute of Oncology
Investigators
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Study Director: Barbara A Jereczek-Fossa, Prof Istituto Europeo di Oncologia IRCCS Milan, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jereczek Barbara, MD, Professor/ Head of the Radiotherapy Division, European Institute of Oncology
ClinicalTrials.gov Identifier: NCT03940235     History of Changes
Other Study ID Numbers: Istituto Europeo di Oncologia
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 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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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs