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

NCT05003752 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Not yet assigned
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Adenocarcinoma; Radiation Toxicity

Keywords

HDR-Brachytherapy; EBRT; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity

  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 Outcomes (6)

• Rate of biochemical control

  2 years, 5 years

• Rate of overall survival

  2 years, 5 years

• Rate of prostate cancer-specific survival

  2 years, 5 years

• Rate of distant metastasis-free survival

  2 years, 5 years

• Rate of treatment-related symptoms on Quality of Life assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire

  2 years, 5 years

Study Arms (1)

Hypofractionated EBRT plus HDR-BT boost

OTHER

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; Drug: Goserelin 10.8 mg

Interventions

External beam radiation therapy, High-dose-rate brachytherapy RADIATION

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)

Hypofractionated EBRT plus HDR-BT boost

Goserelin 10.8 mg DRUG

Androgen deprivation will be administered based on NCCN guidelines in patients with unfavorable intermediate/high risk organ-confined prostate cancer

Also known as: Androgen deprivation therapy (upon indication)

Hypofractionated EBRT plus HDR-BT boost

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• German Oncology Center, Cyprus: lead

Study Sites (1)

German Oncology Center

Limassol, 4108, Cyprus

Location

MeSH Terms

Conditions

Radiation Injuries; Prostatic Neoplasms

Interventions

Goserelin; Androgen Antagonists

Condition Hierarchy (Ancestors)

Wounds and Injuries; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Iosif Strouthos, MD PhD

  German Oncology Center, Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2022
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)