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Prostate AdenocarcinomaPhase 1/2Hypo-CombiNCT05003752

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

A Phase 1/2 study testing External beam radiation therapy, High-dose-rate brachytherapy and Goserelin 10.8 mg in people with Prostate Adenocarcinoma and Radiation Toxicity, run by German Oncology Center, Cyprus at 1 site in Cyprus.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Adenocarcinoma, Radiation Toxicity
What is being tested?
External beam radiation therapy, High-dose-rate brachytherapy and Goserelin 10.8 mg
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCyprus
Study dates
1 Aug 2021to 1 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

  • German Oncology Center

    Limassol, 4108

Other trials in Cyprus

About this study

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

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

Read the 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.

Being tested
External beam radiation therapy, High-dose-rate brachytherapy, Goserelin 10.8 mg
Keywords
HDR-Brachytherapy, EBRT, Prostate cancer
Medical subject headings
Radiation Injuries, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External beam radiation therapy, High-dose-rate brachytherapyRadiation

    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)

  • Goserelin 10.8 mgDrug

    Also called Androgen deprivation therapy (upon indication)

    Androgen deprivation will be administered based on NCCN guidelines in patients with unfavorable intermediate/high risk organ-confined prostate cancer

Study groups in NCT05003752
Study groupRoleWhat they receive
Hypofractionated EBRT plus HDR-BT boostOtherPrimarily 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.
Receives: Radiation: External beam radiation therapy, High-dose-rate brachytherapy; Drug: Goserelin 10.8 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 2 years

Secondary outcomes (6)

  1. Rate of biochemical control

    Evaluation of 2- and 5-year biochemical control based on the Phoenix criteria

    Measured: 2 years, 5 years

  2. Rate of overall survival

    Evaluation of 2- and 5-year overall survival rate

    Measured: 2 years, 5 years

  3. Rate of prostate cancer-specific survival

    Evaluation of 2- and 5-year prostate cancer-specific survival rate

    Measured: 2 years, 5 years

  4. Rate of distant metastasis-free survival

    Evaluation of 2- and 5-year distant metastasis-survival rate

    Measured: 2 years, 5 years

  5. 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.

    Measured: 2 years, 5 years

  6. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Aug 2021
  3. Primary completion31 Dec 2022
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05003752
Sponsor's protocol ID
Not yet assigned
Acronym
Hypo-Combi
Status last verified
Sep 2026
First submitted
29 Jun 2021
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data regarding this study will be presented at international meetings. Manuscripts will be submitted to peer-reviewed Journals

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing External beam radiation therapy, High-dose-rate brachytherapy and Goserelin 10.8 mg in people with Prostate Adenocarcinoma and Radiation Toxicity, run by German Oncology Center, Cyprus at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05003752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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