Determine the safety (oncologica! outcome and toxicity) of an comprehensive treatment combining recent advances in the treatmentof high risk prostate cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biochemical recurrence free survival and late toxicity
Secondary outcome
Overall survival; Metastasis Free survival at 5 years; pattern of failure
(based on PSMA in case of biochemical recurrence)
Background summary
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.
Study objective
Determine the safety (oncologica! 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 controlgroup
Intervention
Hypofractionated pelvic radiotherapy with boost to primary tumor in the
prostate
Study burden and risks
The total number of irradiations is reduced from 25 to 5, which reduces the
patient's burden compared to standard treatment.
This treatment is expected to have similar outcomes (oncologica! outcome/
toxicity). This will be evaluated in an interim analysis
with clearly defined stopping criteria.
Stopping rule: If short term toxicity >= grade 3 exceeds 8%, no further
patients will be included
Burgemeester Banninglaan 1
Leidschendam 2262BA
NL
Burgemeester Banninglaan 1
Leidschendam 2262BA
NL
Listed location countries
Age
Inclusion criteria
• Men (aged >18 years of age) diagnosed within 6 months before inclusion with
igh risk prostate cancer. • T3 based on digital rectal examination AND/OR o
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)
Exclusion criteria
•Prior pelvic radiotherapy
• TransUrethral Resection of the Prostate (TURP) &It; 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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85572.058.23 |