Oligometastatic Prostate CancerPhase 2RADIOSANCT03940235
Radioablation With or Without Androgen DeprIvation Therapy in Metachronous Prostate Cancer OligometaStAsis
A Phase 2 study testing Androgen deprivation therapy (ADT) and SBRT in people with Oligometastatic Prostate Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oligometastatic Prostate Cancer
- What is being tested?
- Androgen deprivation therapy (ADT) and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 1 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, MI - Milano, 20135
Barbara A Jereczek-Fossa, Prof, +39 0257489037, barbara.jereczek@ieo.it
About this study
Official title: Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
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.
- Conditions
- Oligometastatic Prostate Cancer
- Being tested
- Androgen deprivation therapy (ADT), SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen deprivation therapy (ADT)Drug
SBRT + ADT
SBRTRadiation
SBRT to all radiological documented lesions (bone or lymphnodes)
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body Radiotherapy (SBRT) only | Experimental | ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously. Receives: Radiation: SBRT |
| Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT) | Active comparator | 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. Receives: Drug: Androgen deprivation therapy (ADT); Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.
Measured: up 3 months from the end of the treatment up to radiological progression within 3 years
Secondary outcomes (3)
Overall survival (OS)
From the end of RT treatment to the time of clinical progression or mortality from specific disease cause
Measured: Up the end of SBRT until death for cancer or other causes up to 3 years
Biochemical progression-free survival (BPFS)
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.
Measured: up 3 months from the end of the treatment up to 3 years
Numbers of patients who experienced acute and late toxicity
Toxicity will be assessed according to the Common Toxicity Criteria for adverse events (CTCAE) toxicity criteria v4.3
Measured: Up to 1 months after treatment completion and then up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara A Jereczek-Fossa, Prof, Study director, Istituto Europeo di Oncologia IRCCS Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940235
- Sponsor's protocol ID
- IEO 997
- Acronym
- RADIOSA
- Status last verified
- Jun 2023
- First submitted
- 24 Apr 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vavassori A, Mauri G, Mazzola GC, Mastroleo F, Bonomo G, Durante S, Zerini D, Marvaso G, Corrao G, Ferrari ED, Rondi E, Vigorito S, Cattani F, Orsi F, Jereczek-Fossa BA. Cyberknife Radiosurgery for Prostate Cancer after Abdominoperineal Resection (CYRANO): The Combined Computer Tomography and Electromagnetic Navigation Guided Transperineal Fiducial Markers Implantation Technique. Curr Oncol. 2023 Aug 28;30(9):7926-7935. doi: 10.3390/curroncol30090576.
PubMed 37754491Carloni G, Garibaldi C, Marvaso G, Volpe S, Zaffaroni M, Pepa M, Isaksson LJ, Colombo F, Durante S, Lo Presti G, Raimondi S, Spaggiari L, de Marinis F, Piperno G, Vigorito S, Gandini S, Cremonesi M, Positano V, Jereczek-Fossa BA. Brain metastases from NSCLC treated with stereotactic radiotherapy: prediction mismatch between two different radiomic platforms. Radiother Oncol. 2023 Jan;178:109424. doi: 10.1016/j.radonc.2022.11.013. Epub 2022 Nov 24.
PubMed 36435336Marvaso G, Ciardo D, Corrao G, Gandini S, Fodor C, Zerini D, Rojas DP, Augugliaro M, Bonizzi G, Pece S, Cattani F, Mazzocco K, Mistretta FA, Musi G, Alessi S, Petralia G, Pravettoni G, De Cobelli O, Di Fiore PP, Viale G, Orecchia R, Jereczek-Fossa BA. Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159). BMC Cancer. 2019 Sep 10;19(1):903. doi: 10.1186/s12885-019-6117-z.
PubMed 31500605
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
- ClinicalTrials.gov ID
- NCT03940235
- Acronym / sponsor ID
- RADIOSA / IEO 997
- Conditions
- Oligometastatic Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body Radiotherapy (SBRT) only | Experimental | Radiation: SBRTARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously. |
| Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT) | Active comparator | Drug: Androgen deprivation therapy (ADT), Radiation: SBRTARM 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen deprivation therapy (ADT)SBRT + ADT | Drug | Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT) |
| SBRTSBRT to all radiological documented lesions (bone or lymphnodes) | Radiation | Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT), Stereotactic body Radiotherapy (SBRT) only |
Primary outcome
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.
3 secondary outcomes
Overall survival (OS)
Time frame: Up the end of SBRT until death for cancer or other causes up to 3 years
Biochemical progression-free survival (BPFS)
Time frame: up 3 months from the end of the treatment up to 3 years
Numbers of patients who experienced acute and late toxicity
Time frame: Up to 1 months after treatment completion and then up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 37754491Vavassori A, Mauri G, Mazzola GC, Mastroleo F, Bonomo G, Durante S, Zerini D, Marvaso G, Corrao G, Ferrari ED, Rondi E, Vigorito S, Cattani F, Orsi F, Jereczek-Fossa BA. Cyberknife Radiosurgery for Prostate Cancer after Abdominoperineal Resection (CYRANO): The Combined Computer Tomography and Electromagnetic Navigation Guided Transperineal Fiducial Markers Implantation Technique. Curr Oncol. 2023 Aug 28;30(9):7926-7935. doi: 10.3390/curroncol30090576.
- Derived from this study: PubMed 36435336Carloni G, Garibaldi C, Marvaso G, Volpe S, Zaffaroni M, Pepa M, Isaksson LJ, Colombo F, Durante S, Lo Presti G, Raimondi S, Spaggiari L, de Marinis F, Piperno G, Vigorito S, Gandini S, Cremonesi M, Positano V, Jereczek-Fossa BA. Brain metastases from NSCLC treated with stereotactic radiotherapy: prediction mismatch between two different radiomic platforms. Radiother Oncol. 2023 Jan;178:109424. doi: 10.1016/j.radonc.2022.11.013. Epub 2022 Nov 24.
- Derived from this study: PubMed 31500605Marvaso G, Ciardo D, Corrao G, Gandini S, Fodor C, Zerini D, Rojas DP, Augugliaro M, Bonizzi G, Pece S, Cattani F, Mazzocco K, Mistretta FA, Musi G, Alessi S, Petralia G, Pravettoni G, De Cobelli O, Di Fiore PP, Viale G, Orecchia R, Jereczek-Fossa BA. Radioablation +/- hormonotherapy for prostate cancer oligorecurrences (Radiosa trial): potential of imaging and biology (AIRC IG-22159). BMC Cancer. 2019 Sep 10;19(1):903. doi: 10.1186/s12885-019-6117-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A Jereczek-Fossa, Prof study director
Istituto Europeo di Oncologia IRCCS Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen deprivation therapy (ADT) and SBRT in people with Oligometastatic Prostate Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara A Jereczek-Fossa, Prof (+39 0257489037, barbara.jereczek@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up 3 months from the end of the treatment up to radiological progression within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.