Prostatic NeoplasmPhase 2esSBRTNCT05667636
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
A Phase 2 study testing salvage SBRT in people with Prostatic Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- salvage SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2022to 27 Sep 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
- - Able and willing to provide informed consent;
- Pathologically proven diagnosis of prostatic adenocarcinoma;
- Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;
- No regional or distant metastases;
- Eastern Cooperative Oncology Group performance status 0-1
Who cannot join
- - Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;
- Previous radiotherapy to the pelvis;
- Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);
- PSA level at sRT> 2 ng/ml;
- (Each single) Lesion volume within the prostatic fossa at mpMR >5 cc;
- Previous chemotherapy for malignancy in past 5 years;
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- Previous androgen deprivation for biochemical failure after RP;
- Contraindication to short term AD (in case of Px)
- Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT
- Pathologically positive lymph nodes (pN+) at RP;
- Serious medical comorbidities or other contraindications to radiotherapy
- Presence of active inflammatory bowel disease;
- Presence of active connective tissue disease;
- Unable or unwilling to complete quality of life questionnaires
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Regina Elena National Cancer Institute
Rome, 00144
giuseppe sanguineti, Professor, 0652661530, giuseppe.sanguineti@ifo.it
Paola Franzoso, DM, 0652666125, paola.franzoso@ifo.it
About this study
Official title: Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.
The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
Read the detailed description
The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.
Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
- Conditions
- Prostatic Neoplasm
- Being tested
- salvage SBRT
- Keywords
- prostate cancer;, biochemical recurrence;, salvage radiotherapy;, SBRT;
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage SBRTRadiation
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| single arm, non randomized | Experimental | SBRT 30 Gy/ 5 fractions Receives: Radiation: salvage SBRT |
| radiation, SBRT | Experimental | SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes Receives: Radiation: salvage SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-yr BFFS
The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP
Measured: 3-years
Secondary outcomes (6)
3-y OS
The secondary objective is 3-yr overal survival
Measured: 3-years
3-y LC
The secondary objective is 3-yr locoregional control assessed with PSA
Measured: 3-years
3-y MFS
The secondary objective is 3-yr metastases free survival
Measured: 3-years
3-y GU GI tox
The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0
Measured: 3-years
3-y QoL
The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)
Measured: 3-years
3-y - Patient satisfaction with treatment
The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start27 Sep 2022
- Primary completion27 Sep 2023 (estimated)
- Study completion27 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alessia Farneti, Adriana Faiella, Marta Bottero, Pasqualina D'Urso, Valeria Landoni, Antonella Soriani, Luca Bertini
- Responsible party
- Principal investigator, Giuseppe Sanguineti, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667636
- Sponsor's protocol ID
- RS1705/22 (2678)
- Acronym
- esSBRT
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
- ClinicalTrials.gov ID
- NCT05667636
- Acronym / sponsor ID
- esSBRT / RS1705/22 (2678)
- Conditions
- Prostatic Neoplasm
- Keywords
- prostate cancer;, biochemical recurrence;, salvage radiotherapy;, SBRT;
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Alessia Farneti, Adriana Faiella, Marta Bottero, Pasqualina D'Urso, Valeria Landoni, Antonella Soriani, Luca Bertini
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Sep 2023 (estimated)
- Study completion
- 27 Sep 2024 (estimated)
- First posted
- 28 Dec 2022 (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.
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.
The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
Detailed description
The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.
Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single arm, non randomized | Experimental | Radiation: salvage SBRTSBRT 30 Gy/ 5 fractions |
| radiation, SBRT | Experimental | Radiation: salvage SBRTSBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Able and willing to provide informed consent;
- Pathologically proven diagnosis of prostatic adenocarcinoma;
- Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;
- No regional or distant metastases;
- Eastern Cooperative Oncology Group performance status 0-1
Key exclusion criteria (14 listed)
- - Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;
- Previous radiotherapy to the pelvis;
- Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);
- PSA level at sRT> 2 ng/ml;
- (Each single) Lesion volume within the prostatic fossa at mpMR >5 cc;
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 |
|---|---|---|
| salvage SBRTsteretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer | Radiation | radiation, SBRT, single arm, non randomized |
Primary outcome
3-yr BFFS
Time frame: 3-years
The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP
6 secondary outcomes
3-y OS
Time frame: 3-years
3-y LC
Time frame: 3-years
3-y MFS
Time frame: 3-years
3-y GU GI tox
Time frame: 3-years
3-y QoL
Time frame: 3-years
3-y - Patient satisfaction with treatment
Time frame: 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 Dec 2022.
- 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.
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 salvage SBRT in people with Prostatic Neoplasm, run by Regina Elena Cancer Institute 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 5 inclusion and 14 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 Dec 2022. 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 Giuseppe Sanguineti, Professor (0652663015, giuseppe.sanguineti@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-yr BFFS (time frame: 3-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2022.