Prostate CancerNCT06220435
Tumor-directed Radiation Therapy for Patients With the Highest Risk Category of Localized Prostate Cancer
A study testing Ultra-hypofractionated radiotherapy regimen. in people with Prostate Cancer, run by Region Skane at 2 sites in Sweden.
Trial summary
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ultra-hypofractionated radiotherapy regimen.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesSweden
- Study dates
- 25 Sep 2023to 1 Sep 2031
- Phase
- Interventional
- 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
- Life expectancy >5 years
- Age ≥18 years
- World Health Organization (WHO) performance status 0-2
- Histological evidence of prostate cancer
- Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
- At least one Prostate Imaging-Reporting and Data System (PI-RADS) 4-5 lesion on diagnostic Magnetic resonance imaging (MRI)
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- Patients must be able to comply with the protocol
- Signed informed consent
- Adequate laboratory findings: haemoglobin (Hb) >90 g/L, absolute neutrophil count >1.0x10^9/l, platelets >75x10^9/l, bilirubin <2.0 x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <2.0x ULN)
Who cannot join
- Regional or distant metastasis
- Any contraindications for MRI
- PSA >150 ng/ml
- Previous pelvic radiotherapy
- Prior prostate surgery including transurethral resection of the prostate (TURP)
- Endocrine treatment (past or present)
Show all 9Show fewer
- Other malignancies than prostate cancer and basalioma in the past five years
- Serious disease state that makes study inclusion and treatment unsuitable
- Severe lower urinary tract symptoms (International Prostate Symptom Score (IPSS) ≥20)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Skåne, Skåne University Hospital
Lund
Adalsteinn Gunnlaugsson, MD, PhD, +46 4617 6268, Adalsteinn.Gunnlaugsson@skane.se
Clinical Trials Office, cto.hematologi_onkologi.se@skane.se
- Recruiting
Region Västerbotten, Umeå University Hospital
Umeå
Karin Söderkvist, MD, PhD, +46907851000, karin.soderkvist@umu.se
About this study
Official title: Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.
Read the detailed description
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.
Specific aims of the study are:
- To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).
- To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.
- To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.
- Conditions
- Prostate Cancer
- Being tested
- Ultra-hypofractionated radiotherapy regimen.
- Keywords
- very high risk prostate cancer, radiotherapy, localized prostate cancer treatment, ultra-hypofractionated radiation boost
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionated radiotherapy regimen.Radiation
- Prostate tumor(s): 49 Gray (Gy)/7 fractions
- Prostate gland: 42.7 Gy/7 fractions
- Elective lymph nodes: 29.4 Gy/7 fractions
- Seminal vesicles: 31.15 Gy/7 fractions
| Study group | Role | What they receive |
|---|---|---|
| HYPO-RT-PC boost | Experimental | Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation. Receives: Radiation: Ultra-hypofractionated radiotherapy regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3+ Genitourinary Adverse Events
Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: start of treatment - 5 years
Secondary outcomes (11)
Grade 2+ Genitourinary Adverse Events
Acute grade 2+ genitourinary Adverse Events according to CTCAE v5.0.
Measured: start of treatment - 5 years
Failure-free survival
Measured: consent date - 5 years
Local failure-free survival
Measured: enrollment date - 5 years
Biochemical failure-free survival
Measured: enrollment date - 5 years
Cancer-specific survival
Measured: enrollment date - 5 years
Overall survival failure-free survival, cancer-specific survival, and overall survival
Measured: enrollment date - 5 years
Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival
Measured: enrollment date - 5 years
Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival
Measured: enrollment date - 5 years
Adverse Events according to CTCAE v5.0
Measured: start of treatment - 5 years
Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30)
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: inclusion date - 5 years
Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25)
It includes subscales assessing urinary symptoms, bowel symptom), treatment-related symptom) and sexual functioning with score from 0 to 4 per item. A high scale score represents a higher response level.
Measured: inclusion date - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start25 Sep 2023
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adalsteinn Gunnlaugsson, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220435
- Sponsor's protocol ID
- HYPO-RT-PC boost
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Image-guided Ultra-hypofractionated Focal Boost to Intraprostatic Lesion(s) With Lymph Node Irradiation for a Very High High-risk Localized Prostate Cancer (the HYPO-RT-PC Boost Trial)
- ClinicalTrials.gov ID
- NCT06220435
- Acronym / sponsor ID
- HYPO-RT-PC boost
- Conditions
- Prostate Cancer
- Keywords
- very high risk prostate cancer, radiotherapy, localized prostate cancer treatment, ultra-hypofractionated radiation boost
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.
Detailed description
HYPO-RT-PC boost is is an open-label, multicentre, phase II trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study.
Specific aims of the study are:
- To study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome).
- To study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer.
- To study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYPO-RT-PC boost | Experimental | Radiation: Ultra-hypofractionated radiotherapy regimen.Ultra-hypofractionated seven-fraction radiotherapy regimen including focal boost and lymph node irradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Life expectancy >5 years
- Age ≥18 years
- World Health Organization (WHO) performance status 0-2
- Histological evidence of prostate cancer
- Classified as very high-risk according to national guidelines (2-3 of following high risk criteria: T3 / Gleason grade 8 /Prostate-specific antigen (PSA) 20-49 μg/L or and/or Gleason score 9-10 and/or PSA ≥40 μg/L
Key exclusion criteria (9 listed)
- Regional or distant metastasis
- Any contraindications for MRI
- PSA >150 ng/ml
- Previous pelvic radiotherapy
- Prior prostate surgery including transurethral resection of the prostate (TURP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-hypofractionated radiotherapy regimen.* Prostate tumor(s): 49 Gray (Gy)/7 fractions * Prostate gland: 42.7 Gy/7 fractions * Elective lymph nodes: 29.4 Gy/7 fractions * Seminal vesicles: 31.15 Gy/7 fractions | Radiation | HYPO-RT-PC boost |
Primary outcome
Grade 3+ Genitourinary Adverse Events
Time frame: start of treatment - 5 years
Acute grade 3+ genitourinary Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
11 secondary outcomes
Grade 2+ Genitourinary Adverse Events
Time frame: start of treatment - 5 years
Failure-free survival
Time frame: consent date - 5 years
Local failure-free survival
Time frame: enrollment date - 5 years
Biochemical failure-free survival
Time frame: enrollment date - 5 years
Cancer-specific survival
Time frame: enrollment date - 5 years
Overall survival failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Distant metastasis-free survival failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Time to systemic therapy failure-free survival, cancer-specific survival, and overall survival
Time frame: enrollment date - 5 years
Adverse Events according to CTCAE v5.0
Time frame: start of treatment - 5 years
Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C-30)
Time frame: inclusion date - 5 years
Health-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire PR-25 (EORTC QLQ-PR25)
Time frame: inclusion date - 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adalsteinn Gunnlaugsson, MD, PhD principal investigator
Region Skåne, Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-hypofractionated radiotherapy regimen. in people with Prostate Cancer, run by Region Skane at 2 sites in Sweden.
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 9 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
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?
Contact Adalsteinn Gunnlaugsson, MD, PhD (+46 4617 6268, Adalsteinn.Gunnlaugsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3+ Genitourinary Adverse Events (time frame: start of treatment - 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.