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

NCT05003752 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • German Oncology Center, Cyprus

    lead OTHER

Principal Investigators

  • Iosif Strouthos, MD PhD · German Oncology Center, Cyprus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-31
Completion
2026-08-01

Countries

  • Cyprus

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003752 on ClinicalTrials.gov