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

Prostate Adenocarcinoma Clinical Trial

— Hypo-Combi  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05003752
• Other study ID #: Not yet assigned
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 1, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: March 2023
• Source: German Oncology Center, Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 1, 2026
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Radiation Toxicity

Intervention

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)

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

Locations

Country	Name	City	State
Cyprus	German Oncology Center	Limassol

Sponsors (1)

Lead Sponsor	Collaborator
German Oncology Center, Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of biochemical control	Evaluation of 2- and 5-year biochemical control based on the Phoenix criteria	2 years, 5 years
Secondary	Rate of overall survival	Evaluation of 2- and 5-year overall survival rate	2 years, 5 years
Secondary	Rate of prostate cancer-specific survival	Evaluation of 2- and 5-year prostate cancer-specific survival rate	2 years, 5 years
Secondary	Rate of distant metastasis-free survival	Evaluation of 2- and 5-year distant metastasis-survival rate	2 years, 5 years
Secondary	Rate of treatment-related symptoms on Quality of Life assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire	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
Secondary	18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries	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