Prostate CancerDART-PHASERNCT05884632
Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
A study testing Daily Adaptive RadioTherapy in people with Prostate Cancer, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Daily Adaptive RadioTherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2023to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≤ 80 years;
- Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
- Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
- No distant metastases (M0) diagnosed with PSMA-PET-CT;
- Informed consent to trial's participation and personal data treatment.
Who cannot join
- Age <18 years old;
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria di Negrar
Negrar, Verona, 37024
Luca Nicosia, Doctor, +39(0)456014800, luca.nicosia@sacrocuore.it
About this study
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.
Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.
- Conditions
- Prostate Cancer
- Being tested
- Daily Adaptive RadioTherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Adaptive RadioTherapyRadiation
Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy Receives: Radiation: Daily Adaptive RadioTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute gastrointestinal toxicity
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.
Measured: 90 days from the RT treatment
Secondary outcomes (7)
Acute genitourinary toxicity
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any genitourinary event occurred within 90 days from the RT treatment.
Measured: 90 days from the RT treatment.
Late toxicity
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0), and by patient-reported outcome according to the EPIC questionnaire. More specifically, late toxicity will be defined as any event (genitourinary and gastrointestinal) occurred from 90 days after the RT treatment.
Measured: From 90 days after the RT treatment until 24 months
QLQ-C30
Patient-reported outcomes will be assessed via the EORTC global (QLQ-C30) questionnaires at screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
Measured: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
Biochemical failure
PSA raise after RT from nadir
Measured: 24 months
Time to biochemical failure
Time between salvage RT and biochemical failure
Measured: 24 months
Local in-field relapse
Local in-field relapse evaluated with PET-CT or RM
Measured: 24 months
Metastases-free survival
Metastases-free survival evaluated with PSMA PET-TC in case of PSA raise
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start3 Apr 2023
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Nicosia, Principal investigator, IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884632
- Sponsor's protocol ID
- 2022-51
- Acronym
- DART-PHASER
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05884632
- Acronym / sponsor ID
- DART-PHASER / 2022-51
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 1 Jun 2023 (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.
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence.
Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Radiation: Daily Adaptive RadioTherapyPatients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≤ 80 years;
- Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
- Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA <0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
- No distant metastases (M0) diagnosed with PSMA-PET-CT;
- Informed consent to trial's participation and personal data treatment.
Key exclusion criteria (3 listed)
- Age <18 years old;
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
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 |
|---|---|---|
| Daily Adaptive RadioTherapyPatients will be treated on the prostate bed with Ethos using daily-adaptive modality with the dose of 59 Gy in 20 daily fractions of 2.95 Gy | Radiation | Treatment arm |
Primary outcome
Acute gastrointestinal toxicity
Time frame: 90 days from the RT treatment
Will be evaluated by physician-reported outcome according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and by patient-reported outcome according to the EPIC questionnaire. More specifically, acute toxicity will be defined as any gastrointestinal event occurred within 90 days from the RT treatment with grade ≥G2.
7 secondary outcomes
Acute genitourinary toxicity
Time frame: 90 days from the RT treatment.
Late toxicity
Time frame: From 90 days after the RT treatment until 24 months
QLQ-C30
Time frame: At screening, 2nd and 4th week during RT, at 3, 6, 12, and 24 months
Biochemical failure
Time frame: 24 months
Time to biochemical failure
Time frame: 24 months
Local in-field relapse
Time frame: 24 months
Metastases-free survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
Luca Nicosia principal investigator
IRCCS Sacro Cuore Don Calabria - Dipartimento di Radioterapia Oncologica Avanzata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Adaptive RadioTherapy in people with Prostate Cancer, run by IRCCS Sacro Cuore Don Calabria di Negrar 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 3 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: looking for participants now, as of the sponsor's last update on 1 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute gastrointestinal toxicity (time frame: 90 days from the RT treatment). 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 1 Jun 2023.