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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

German Oncology Center, Cyprus

Investigators

  • 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)

August 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Not yet assigned

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.

Clinical Trials on Prostate Adenocarcinoma

Clinical Trials on External beam radiation therapy, High-dose-rate brachytherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe