Prostate CancerNCT04484038
Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
A study testing hypofractionated postoperative radiation therapy in people with Prostate Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 19 sites in Spain.
Trial summary
The objective of this study is to evaluate, in patients diagnosed with prostate cancer who undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and survival, as well as of quality of life, from… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- hypofractionated postoperative radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 19 sitesSpain
- Study dates
- 9 Mar 2019to Mar 2025
- Phase
- Interventional
- 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
- Age ≥ 18 years.
- ECOG 0-1 status.
- Previous radical prostatectomy (any modality will be allowed) with or without lymphadenectomy.
- Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.
- pT2-T3 Version 2.0, March 27, 2019
- pN0-Nx
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- Indication of postoperative RT:
- Adjuvant RT: pT3 and / or positive margins with PSA <0.2 ng / ml. Delayed RT is considered (> 6 months from the date of surgery but PSA <0.2 ng / ml).
- Rescue RT: exclusive biochemical recurrence, without evidence of macroscopic local, regional or distant disease, after surgery. Biochemical recurrence is considered PSA ≥ 0.2 ng / ml after undetectable levels, confirmed with a subsequent determination.
- PSA levels ≤ 2 ng / ml after, at least 45 days after surgery and 30 days before inclusion in the study.
- No clinical evidence of lymph node disease. The presence will be admitted by imaging tests of pelvic nodes ≤ 1 cm in its shortest axis.
- No evidence of disease in the prostatic fossa. If you doubt by digital rectal examination or CT, an MRI will be performed.
- No evidence of distant disease after performing a thoraco-abdominal-pelvic CT scan and bone scan.
- Reasonable follow-up possibilities.
- Ability to complete the EPIC-26 questionnaire.
- Written informed consent prior to inclusion in the study.
Who cannot join
- - Previous pelvic radiation therapy.
- Distant metastasis.
- Macroscopic residual tumor.
- PSA> 2 ng / ml.
- Pathological stage T4.
- Lymph node involvement.
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- Pelvic or para-aortic nodules in the reevaluation images after surgery, except pelvic nodes ≤ 1 cm in their shortest axis.
- Indication of pelvic nodal RT. Version 2.0, March 27, 2019
- Severe urinary incontinence at the time of indication for radiotherapy.
- Uni / bilateral hip prosthesis
- Previous tumors, except non-melanoma skin carcinoma, and which are not free of disease for at least 3 years from the end of the treatment of said neoplasms. Bladder tumors are excluded in all cases.
- Genetic hyper-radio-sensitivity syndromes.
- Chronic inflammatory bowel disease or partial or radical cystectomy for any reason.
- Previously treated with androgen deprivation therapy for a period greater than 3 months.
- Previously treated with chemotherapy for prostate cancer.
- Life expectancy <5 years or severe comorbidity: unstable angina, congestive heart failure, transmural myocardial infarction requiring admission in the last 6 months, active infectious process, respiratory disease requiring hospitalization, liver failure (Child-Pugh Class B or C), HIV with a CD4 count <200 cells / ml, kidney failure requiring dialysis and immunosuppressed by other causes.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites, 19 recruiting
- Recruiting
Hospital Universitario Torrecárdenas
Almería
Carmen Cano Soler, Investigator, +34950016000, canosolercar@gmail.com
- Recruiting
Hospital Universitario de Badajoz
Badajoz
Julia Muñoz García, Investigator, +34924218100, jlmunozgarcia@gmail.com
- Recruiting
ICO Badalona
Badalona, Barcelona
Ana Álvarez García, Investigator, +34932607733, ana.alvarez@iconcologia.net
- Recruiting
H. Sta. Cruz y San Pablo
Barcelona
Gemma Sancho Pardo, Investigator, +34932919000, gsancho@santpau.cat
- Recruiting
Instituto Oncológico IMQ
Bilbao
Clara Eito Valdovinos, Investigator, +34944755000, c.eito@imq.es
- Recruiting
Hospital de Fuenlabrada
Fuenlabrada, Madrid
Begoña Caballero, +34916006581, begocaba@gmail.com
- Recruiting
Hospital Universitario San Cecilio
Granada
Antonio Lazo Prados, Investigator, 0034958023000, anlaparados@gmail.com
- Recruiting
Hospital Dr. Negrin
Las Palmas de Gran Canaria, Gran Canaria
Juan Ignacio Rodriguez Melcón, Investigator, +34928450284, nachorodriguezmelcon@gmail.com
- Recruiting
Hospital General Gregorio Marañón
Madrid, Adrid
CARMEN GONZALEZ SANSEGUNDO, INVESTIGATOR, +34915868000 ext. +34915868000, cglezss@gmail.com
ANA ALVAREZ, INVESTIGATOR, +34915868000 ext. +34915868000, analvagonza@gmail.com
- Recruiting
Hospital Universitario Ramón Y Cajal
Madrid, 2834
ASUNCIÓN R HERVAS, Investigator, ahervas.hrc@salud.madrid.org
ADELA MARIA López, Data Manager, 0034656303686, adelamaria.lopez@salud.madrid.org
- Recruiting
Fundación Jimenez Díaz 1
Madrid
Jesús Olivera, Investigator, +34915504800, jolivera@fjd.es
- Recruiting
Fundación Jiménez Díaz 2
Madrid
Walter Vasquez Rivas, Investigator, +34915494058, walter.vasquez@quironsalud.es
- Recruiting
Hospital de La Princesa
Madrid
Almudena Zapatero, Investigator, +34915202315, almudena.zapatero@salud.madrid.org
- Recruiting
Hospital La Luz
Madrid
Luis L Guerrero Gómez, Investigator, +34914521900, leoguerrero01@gmail.com
- Recruiting
Hospital Quirón
Madrid
Felipe Couñago Lorenzo, Investigator, +34914521900, fcounago@gmail.com
- Recruiting
Hospital Ruber Internacional
Madrid
Aurora Rodríguez Pérez, INVESTIGATOR, 0034913875288, aurora.rodriguezp@ruberinternacional.es
- Recruiting
Complejo Hospitalario de Navarra
Pamplona
Marta Barrado Los Arcos, Investigator, +34848428482, marta.barrado.losarcos@navarra.es
Margarita Illas Pérez-Mosso, Investigator, +34848428482, margarita.illas.perezmosso@navarra.es
- Recruiting
Hospital Universitario de San Juan
San Juan, Alicante
Sandra González Montiel, Investigator, +34965169400, Sandra.19792@gmail.com
- Recruiting
Hospital Universitario de Santiago
Santiago de Compostela, La Coruña
Ana María Carballo Castro, Investigator, +34981950000, ana.maria.carballo.castro@sergas.es
About this study
The objective of this study is to evaluate, in patients diagnosed with prostate cancer who undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and survival, as well as of quality of life, from a hypofractional external radiotherapy scheme, increasing the dose per fraction in a shorter period of time.
Read the detailed description
What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25 daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019
(assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly rectum and bladder) will be governed by the ratio used and will differ depending on whether acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84 Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late toxicity.
Therefore, what the investigators expect is a toxicity profile that is at least similar, if not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and similar rates of biochemical control and survival.
To all this is added the use of intensity modulated radiotherapy and image-guided radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the dose administered to risk organs.
- Conditions
- Prostate Cancer
- Being tested
- hypofractionated postoperative radiation therapy
- Keywords
- Radiotherapy, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypofractionated postoperative radiation therapyRadiation
The patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same.
| Study group | Role | What they receive |
|---|---|---|
| IMRT, any mode | Other | External radiation therapy with 6-18 MV photons on the 62.5 Gy prostate bed in 25 2.5 Gy fractions (EQD2 71 Gy).
Serving per fraction: 2.5 Gy Total fractions: 25 No. fractions / week: 5 Total treatment time: 5 weeks Total nominal dose: 62.5 Gy EQD3 (TRT): 68.75 Gy EQD1.5 (CaP): 71.43 Gy EQD2 (CaP): 68.75 Gy EQD10 (TRA): 65.10 Gy Receives: Radiation: hypofractionated postoperative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related gastrointestinal and genitourinary acute adverse events
using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).
Measured: ≤90 days
Incidence of late gastrointestinal and genitourinary adverse events
using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).
Measured: up to 3 years
Secondary outcomes (5)
Biochemical failure-free survival
Time elapsed between the date of inclusion in the study and biochemical failure
Measured: up to 3 years
Disease-free survival (locoregional and / or remote)
Time elapsed between the date of inclusion in the study and the detection of the disease locally, regionally and / or remotely
Measured: up to 3 years
Overall survival
Time elapsed between the date of inclusion in the study and the patient's death from any cause
Measured: up to 3 years
Cause-specific survival
Time elapsed between the date of inclusion in the study and the patient's death due to prostate cancer or toxicity derived from treatment
Measured: up to 3 years
Assessment of quality of life for cancer Prostate patients
Use of Expanded Prostate Cancer Index questionnaire (EPIC) 26
Measured: at the start of treatment at 3, 12, 24 and 36 months from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start9 Mar 2019
- Primary completionMar 2022 (estimated)
- Study completionMar 2025 (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
- Model description
- This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigación Clínica en Oncología Radioterapia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asunción Hervas, Grupo de Investigación Clínica en Oncología Radioterapia
- Investigators
- ASUNCION R HERVAS, I, Principal investigator, Ramon y Cajal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484038
- Sponsor's protocol ID
- HYPORT-ES
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 23 Jul 2020
- 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 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Hypofractionated Postoperative Radiotherapy in Patients Diagnosed With Prostate Carcinoma
- ClinicalTrials.gov ID
- NCT04484038
- Acronym / sponsor ID
- HYPORT-ES
- Conditions
- Prostate Cancer
- Keywords
- Radiotherapy, prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Grupo de Investigación Clínica en Oncología RadioterapiaUniversity, hospital or other
- Study start
- 9 Mar 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Jul 2020 (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.
The objective of this study is to evaluate, in patients diagnosed with prostate cancer who undergo radical prostatectomy and who require postoperative radiotherapy, tolerance in terms of acute and chronic GU and GI toxicity and efficacy in terms of biochemical control and survival, as well as of quality of life, from a hypofractional external radiotherapy scheme, increasing the dose per fraction in a shorter period of time.
Detailed description
What the investigators present in this study is a hypofractionation scheme of 62.5 Gy in 25 daily fractions of 2.5 Gy / day, which was chosen to provide a biological equivalent dose (BED) of 166.67 Gy, comparable to the 163 Gy administered with a scheme Normally divided up to 70 Gy in daily fractions of 2 Gy / day Version 2.0, March 27, 2019
(assuming an α / β ratio of 1.5 Gy for prostate cancer). The BED in risk organs (mainly rectum and bladder) will be governed by the ratio used and will differ depending on whether acute or late toxicity is calculated. If selected an acute α / β of 10 Gy and a conservative α / β for late toxicity of 3 Gy, the standard fractionation will result in an acute BED of 84 Gy versus 78 Gy in the hypofractionation scheme and a BED of 116.67 vs. 114.5 Gy for late toxicity.
Therefore, what the investigators expect is a toxicity profile that is at least similar, if not slightly better, compared to the norm-fractionated scheme of 70 Gy in 35 fractions and similar rates of biochemical control and survival.
To all this is added the use of intensity modulated radiotherapy and image-guided radiotherapy techniques (IGRT) that will allow the investigators to significantly reduce the dose administered to risk organs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized prospective multicenter study of hypofractionated postoperative radiotherapy in patients diagnosed with prostate carcinoma.
| Arm | Type | Receives |
|---|---|---|
| IMRT, any mode | Other | Radiation: hypofractionated postoperative radiation therapyExternal radiation therapy with 6-18 MV photons on the 62.5 Gy prostate bed in 25 2.5 Gy fractions (EQD2 71 Gy). Serving per fraction: 2.5 Gy Total fractions: 25 No. fractions / week: 5 Total treatment time: 5 weeks Total nominal dose: 62.5 Gy EQD3 (TRT): 68.75 Gy EQD1.5 (CaP): 71.43 Gy EQD2 (CaP): 68.75 Gy EQD10 (TRA): 65.10 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years.
- ECOG 0-1 status.
- Previous radical prostatectomy (any modality will be allowed) with or without lymphadenectomy.
- Histological confirmation of prostate adenocarcinoma in the prostatectomy specimen.
- pT2-T3 Version 2.0, March 27, 2019
Key exclusion criteria (16 listed)
- - Previous pelvic radiation therapy.
- Distant metastasis.
- Macroscopic residual tumor.
- PSA> 2 ng / ml.
- Pathological stage T4.
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 |
|---|---|---|
| hypofractionated postoperative radiation therapyThe patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same. | Radiation | IMRT, any mode |
Primary outcome
Incidence of treatment-related gastrointestinal and genitourinary acute adverse events
Time frame: ≤90 days
using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale. The grades of severity from I (minimum) to V (maximum).
Incidence of late gastrointestinal and genitourinary adverse events
Time frame: up to 3 years
using the Radiation Therapy Oncology Group (RTOG) scale. The grades of severity from 1 (minimum) to 4 (maximum).
5 secondary outcomes
Biochemical failure-free survival
Time frame: up to 3 years
Disease-free survival (locoregional and / or remote)
Time frame: up to 3 years
Overall survival
Time frame: up to 3 years
Cause-specific survival
Time frame: up to 3 years
Assessment of quality of life for cancer Prostate patients
Time frame: at the start of treatment at 3, 12, 24 and 36 months from the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- 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.
ASUNCION R HERVAS, I principal investigator
Ramon y Cajal University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypofractionated postoperative radiation therapy in people with Prostate Cancer, run by Grupo de Investigación Clínica en Oncología Radioterapia at 19 sites in Spain.
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 16 inclusion and 16 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ASUNCION R HERVAS, Investigator (0034649039866, ahervas.hrc@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related gastrointestinal and genitourinary acute adverse events (time frame: ≤90 days). The study lists 2 primary outcomes in all. 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 23 Jul 2020.