Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer (Hypo-Combi)

March 3, 2023 updated by: German Oncology Center, Cyprus

Hypo-Combi Trial: Combined Hypofractionated External Beam Radiation Therapy (EBRT) Plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) Boost for Intermediate/High Risk Prostate Cancer

Hypo-Combi Trial: A Prospective Phase I/II Study of Combined Hypofractionated External Beam Radiation Therapy (EBRT) plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) for Intermediate/High Risk Prostate Cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Phase I/II trial will prospectively assess the acute, early late and late gastrointestinal (GI), genitourinary (GU) and sexual toxicity of combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction) for patients with unfavourable intermediate/high risk (based on NCCN stratification guidelines) organ-confined prostate cancer, not requiring pelvic irradiation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Cyprus
      • Limassol, Cyprus, 4108
        • German Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form
  • Age > 18 years old.
  • Life expectancy of at least five years, excluding his diagnosis of prostate cancer.
  • Histopathologically proven primary adenocarcinoma of the prostate
  • The patient must be registered within 180 days following the histopathological confirmation of the malignancy
  • Prostate volume < 80ml
  • International Prostate Symptom Score (IPSS) < 18
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Patients with a history of non-prostate malignancies are eligible if they have been disease-free for 5 or more years prior to enrolment, are deemed by their physician to be at low risk for recurrence and they did not need pelvic radiotherapy as part of their treatment. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion Criteria:

  • Histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases
  • Prior pelvic radiotherapy
  • Known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma)
  • Prior TURP
  • MRI non compatible metal implants
  • Pre-existing fistulae
  • Contraindication for general and spinal anaesthesia
  • Inability to be placed in lithotomy position
  • Any treatment with radiation therapy, chemotherapy, immunotherapy, biotherapy and/or hormonal therapy for the currently diagnosed prostate cancer prior to registration.
  • History of non-prostate malignancy, apart from patients that have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Hypofractionated EBRT plus HDR-BT boost
Primarily hypofractionated EBRT consisting of 12 x 3 Gy/fraction, TD 36 Gy will be administered. Followed by HDR-BT boost of the prostate, TD 14 Gy.
Radiation: External beam radiation therapy, High-dose-rate brachytherapy
Combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction)
Other Names:
  • Androgen deprivation therapy (upon indication)
Drug: Goserelin 10.8 mg
Androgen deprivation will be administered based on NCCN guidelines in patients with unfavorable intermediate/high risk organ-confined prostate cancer
Other Names:
  • Androgen deprivation therapy (upon indication)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity
Time Frame: up to 2 years
RTOG/EORTC questionnaires will be collected and evaluated for GU/GI toxicity. International Prostate Symptom Score will be assessed for lower urinary tract symptomatology and IIEF-5 for erectile function.
up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of biochemical control
Time Frame: 2 years, 5 years
Evaluation of 2- and 5-year biochemical control based on the Phoenix criteria
2 years, 5 years
Rate of overall survival
Time Frame: 2 years, 5 years
Evaluation of 2- and 5-year overall survival rate
2 years, 5 years
Rate of prostate cancer-specific survival
Time Frame: 2 years, 5 years
Evaluation of 2- and 5-year prostate cancer-specific survival rate
2 years, 5 years
Rate of distant metastasis-free survival
Time Frame: 2 years, 5 years
Evaluation of 2- and 5-year distant metastasis-survival rate
2 years, 5 years
18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries
Time Frame: 2 years
Evaluation of the accuracy of first-line imaging for identifying either pelvic nodal or distant-metastatic disease defined by the receiver-operating curve using a predefined reference-standard including histopathology, imaging, and biochemistry at 6-month follow-up and compare to 18F-PSMA PET/CT
2 years
Rate of treatment-related symptoms on Quality of Life assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire
Time Frame: 2 years, 5 years
Record quality of life (QOL) issues related to treatment-related symptoms and overall satisfaction. Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire will be used. Minimum score is 0 points and maximum score is 60 points, with lower points meaning better quality of life and higher point score meaning, alternatively, worse outcome.
2 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
German Oncology Center, Cyprus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iosif Strouthos, MD PhD, German Oncology Center, Cyprus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Not yet assigned (Istanbul Education and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data regarding this study will be presented at international meetings. Manuscripts will be submitted to peer-reviewed Journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings