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

Phase 1

Active, not recruiting

• Conditions: Prostate Adenocarcinoma; Radiation Toxicity
• Interventions: Radiation: External beam radiation therapy, High-dose-rate brachytherapy; Drug: Goserelin 10.8 mg

• Registration Number: NCT05003752
• Lead Sponsor: German Oncology Center, Cyprus

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

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 Timeline

• Study First Submitted: 2021-06-29
• Study Start: 2021-08-01
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-12
• Primary Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated EBRT plus HDR-BT boost	Goserelin 10.8 mg	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.
Hypofractionated EBRT plus HDR-BT boost	External beam radiation therapy, High-dose-rate brachytherapy	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.

Primary Outcome Measures

Name	Time	Method
Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity	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.

Secondary Outcome Measures

Name	Time	Method
Rate of overall survival	2 years, 5 years	Evaluation of 2- and 5-year overall survival rate
Rate of prostate cancer-specific survival	2 years, 5 years	Evaluation of 2- and 5-year prostate cancer-specific survival rate
18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries	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
Rate of biochemical control	2 years, 5 years	Evaluation of 2- and 5-year biochemical control based on the Phoenix criteria
Rate of distant metastasis-free survival	2 years, 5 years	Evaluation of 2- and 5-year distant metastasis-survival rate
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	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.

Trial Locations

Locations (1)

German Oncology Center; 🇨🇾 Limassol, Cyprus