High Risk Prostate CarcinomaHYPOPRIMENCT06204341
Towards Optimal Treatment for High Risk Prostate Cancer
A study testing HYPOPRIME treatment in people with High Risk Prostate Carcinoma, run by Haaglanden Medical Centre at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High Risk Prostate Carcinoma
- What is being tested?
- HYPOPRIME treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jan 2024to 18 Dec 2032
- 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
- Men (aged ≥18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer:
- T3 based on digital rectal examination AND/OR
- Grade >= 4 AND/OR
- PSA >=20 ug/L
- Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)
Who cannot join
- Prior pelvic radiotherapy
- TransUrethral Resection of the Prostate (TURP) < 3 months ago
- Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)
- contraindications to MRI
- no visible lesion on MRI in prostate for boost
- no PSMA-PET scan
Show all 11Show fewer
- inflammatory bowel disease
- metastatic disease (M1)
- PSA >50
- unsuitable for SBRT or WPRT
- medical history of cancer other than basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Haaglanden Medical Centre
Leidschendam, South Holland, 2262 BA
Carmen P Liskamp, MD, +31 88 9792357, c.liskamp@haaglandenmc.nl
Mirjam E Mast, PhD, 0031889792357, m.mast@haaglandenmc.nl
About this study
Official title: Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments.
- patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation)
- the tumor will get a higher dose
- androgen deprivation therapy will be reduced as much al possible preventing side effects
Researchers will compare oncological outcome and toxicity.
Read the detailed description
Rationale: Recently several randomized trial have shown benefits of changes made to radiotherapy of (high risk) localized prostate cancer patients: A focal boost was shown to improve outcome in men with intermediate/high risk prostate cancer (FLAME trial). Elective lymph node irradiation was shown to improve outcome in high risk prostate cancer patients (POP-RT). (Extreme) hypo fractionation was shown to be safe for low/intermediate risk prostate cancer patients. In addition: the added benefit of ADT (with substantial toxicity) seems reduced with improvements made to treatment and diagnosis in recent years (DART 01/05); own recent work on this topic; to be published)). None off the above were combined into one ideal treatment for high risk prostate cancer.
Objective: Determine the safety (oncological outcome and toxicity) of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer.
Study design: prospective cohort study with matched contemporary control group Study population: Men with high risk prostate cancer with an indication for elective lymph node irradiation Intervention: hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate Main study parameters/endpoints: biochemical recurrence free survival and late toxicity Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden of the study is considered to be low, as additional tests or site visits in comparison to current clinical follow up are not planned. Regarding safety, different parts of the investigational treatment were already shown to be safe in previous studies. The current study aims to combine these different parts into one treatment. We estimate that the risks associated with combining these treatments are very limited.
- Conditions
- High Risk Prostate Carcinoma
- Being tested
- HYPOPRIME treatment
- Keywords
- hypo fractionation, elective lymph node irradiation, focal boost, androgen deprivation therapy reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPOPRIME treatmentRadiation
Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy
| Study group | Role | What they receive |
|---|---|---|
| HYPOPRIME treatment | Experimental | Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy Receives: Radiation: HYPOPRIME treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence free survival
rise of PSA 2 ng/ml above nadir
Measured: 5 years
Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction
according to CTC-AE v5
Measured: at 6 months and 2 years
Secondary outcomes (3)
Metastasis free survival
Metastasis free survival
Measured: 5 years
Overall survival
Overall survival
Measured: 5 years
Pattern of failure
based on PSMA in case of biochemical recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Jan 2024
- Primary completion18 Dec 2032 (estimated)
- Study completion18 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Prostate CarcinomaStudies of the same condition, open and under way.
- 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
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haaglanden Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Tata Memorial Centre
- Responsible party
- Principal investigator, Leonard Bokhorst, Haaglanden Medical Centre
- Investigators
- Leonard P Bokhorst, MD, PhD, Principal investigator, Haaglanden Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204341
- Sponsor's protocol ID
- P23.081
- Acronym
- HYPOPRIME
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Optimal Treatment for High Risk Prostate Cancer; Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
- ClinicalTrials.gov ID
- NCT06204341
- Acronym / sponsor ID
- HYPOPRIME / P23.081
- Conditions
- High Risk Prostate Carcinoma
- Keywords
- hypo fractionation, elective lymph node irradiation, focal boost, androgen deprivation therapy reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Haaglanden Medical CentreUniversity, hospital or other
- Collaborators
- Tata Memorial Centre
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 18 Dec 2032 (estimated)
- Study completion
- 18 Dec 2032 (estimated)
- First posted
- 12 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.
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer. The main question to answer is: is it safe to combine these optimized treatments.
- patients will be irradiated on the prostate and (elective) lymph nodes more concentrated but with fewer hospital visits (hypofractionation)
- the tumor will get a higher dose
- androgen deprivation therapy will be reduced as much al possible preventing side effects
Researchers will compare oncological outcome and toxicity.
Detailed description
Rationale: Recently several randomized trial have shown benefits of changes made to radiotherapy of (high risk) localized prostate cancer patients: A focal boost was shown to improve outcome in men with intermediate/high risk prostate cancer (FLAME trial). Elective lymph node irradiation was shown to improve outcome in high risk prostate cancer patients (POP-RT). (Extreme) hypo fractionation was shown to be safe for low/intermediate risk prostate cancer patients. In addition: the added benefit of ADT (with substantial toxicity) seems reduced with improvements made to treatment and diagnosis in recent years (DART 01/05); own recent work on this topic; to be published)). None off the above were combined into one ideal treatment for high risk prostate cancer.
Objective: Determine the safety (oncological outcome and toxicity) of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer.
Study design: prospective cohort study with matched contemporary control group Study population: Men with high risk prostate cancer with an indication for elective lymph node irradiation Intervention: hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate Main study parameters/endpoints: biochemical recurrence free survival and late toxicity Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The additional burden of the study is considered to be low, as additional tests or site visits in comparison to current clinical follow up are not planned. Regarding safety, different parts of the investigational treatment were already shown to be safe in previous studies. The current study aims to combine these different parts into one treatment. We estimate that the risks associated with combining these treatments are very limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYPOPRIME treatment | Experimental | Radiation: HYPOPRIME treatmentHypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men (aged ≥18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer:
- Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)
Key exclusion criteria (11 listed)
- Prior pelvic radiotherapy
- TransUrethral Resection of the Prostate (TURP) < 3 months ago
- Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc)
- contraindications to MRI
- no visible lesion on MRI in prostate for boost
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 |
|---|---|---|
| HYPOPRIME treatmentHypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy | Radiation | HYPOPRIME treatment |
Primary outcome
Biochemical recurrence free survival
Time frame: 5 years
rise of PSA 2 ng/ml above nadir
Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction
Time frame: at 6 months and 2 years
according to CTC-AE v5
3 secondary outcomes
Metastasis free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Pattern of failure
Time frame: 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 19 Sep 2024.
- 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.
Leonard P Bokhorst, MD, PhD principal investigator
Haaglanden Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYPOPRIME treatment in people with High Risk Prostate Carcinoma, run by Haaglanden Medical Centre at 1 site in Netherlands.
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 5 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Netherlands. 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 Ursula J Fisscher, PhD (0031889792357, u.fisscher@haaglandenmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence free survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 19 Sep 2024.