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

German Oncology Center, Cyprus

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Radiation Toxicity

Prostate Adenocarcinoma

Treatments

Radiation: External beam radiation therapy, High-dose-rate brachytherapy

Drug: Goserelin 10.8 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05003752

Not yet assigned

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.