Clinical trial NCT05003752: Hypo-Combi Trial: Hypofractionated EBRT Plus HDR-BT Boost for Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Adenocarcinoma
Radiation Toxicity
Keywords: HDR-Brachytherapy
EBRT
Prostate cancer
Lead sponsor: German Oncology Center, Cyprus
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity
timeFrame: up to 2 years
Secondary outcomes:
measure: Rate of biochemical control
timeFrame: 2 years, 5 years
measure: Rate of overall survival
timeFrame: 2 years, 5 years
measure: Rate of prostate cancer-specific survival
timeFrame: 2 years, 5 years
measure: Rate of distant metastasis-free survival
timeFrame: 2 years, 5 years
measure: Rate of treatment-related symptoms on Quality of Life assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire
timeFrame: 2 years, 5 years
measure: 18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries
timeFrame: 2 years
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: German Oncology Center
Study officials:
affiliation: German Oncology Center, Cyprus
name: Iosif Strouthos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: