Towards Optimal Treatment for High Risk Prostate Cancer
HYPOPRIME
1 other identifier
interventional
207
1 country
1
Brief 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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2024
CompletedFirst Submitted
Initial submission to the registry
January 3, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 18, 2032
September 19, 2024
January 1, 2024
9 years
January 3, 2024
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biochemical recurrence free survival
rise of PSA 2 ng/ml above nadir
5 years
Late gastrointestinal and genito-urinary toxicity, and erectile dysfunction
according to CTC-AE v5
at 6 months and 2 years
Secondary Outcomes (3)
Metastasis free survival
5 years
Overall survival
5 years
Pattern of failure
5 years
Study Arms (1)
HYPOPRIME treatment
EXPERIMENTALHypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy
Interventions
Hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate with elective lymph node irradiation and minimized androgen deprivation therapy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haaglanden Medical Centrelead
- Tata Memorial Centrecollaborator
Study Sites (1)
Haaglanden Medical Centre
Leidschendam, South Holland, 2262 BA, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
Leonard P Bokhorst, MD, PhD
Haaglanden Medical Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, radiation oncologist
Study Record Dates
First Submitted
January 3, 2024
First Posted
January 12, 2024
Study Start
January 2, 2024
Primary Completion (Estimated)
December 18, 2032
Study Completion (Estimated)
December 18, 2032
Last Updated
September 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share