To assess toxicity of MRI-guided focal salvage high-dose-rate brachytherapy (HDR-BT) in patients with locally recurrent prostate cancer. Secondary objectives are quality of life, biochemical disease free survival, dose restrictions, technical…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of gastrointestinal and/or genitourinary toxicity, which will be
determined by the Common Terminology Criteria for Adverse Events (CTCAE)
version 4.0.
Secondary outcome
- QoL assessment by questionnaires (RAND-36, EORTC QLQ-PR-25, EORTC QLQ-C30,
IPSS, IIEF-5);
- PSA-monitoring for evaluation of biochemical disease free survival;
- Dose restrictions analysis by relating dosage to toxicity to prevent/reduce
toxicity;
- Evaluation of catheter shifts during focal salvage HDR-BT;
- Prediction-modeling for the determination of predictive factors for tumor
control, to further optimize patient selection.
Background summary
Despite improvements in primary curative treatment modalities, prostate cancer
recurrences are common. Various salvage treatments, such as radical
prostatectomy, low-dose-rate-brachytherapy, external beam radiotherapy, high
intensity focused ultrasound and cryosurgery have been investigated. However,
because of high failure and toxicity rates, these treatment modalities remain
unpopular. High failure rates can be reduced by excluding patients with high
risk characteristics for early distant metastases, for whom local salvage
treatment has no benefit. High toxicity rates in whole-gland salvage
irradiation therapies are caused by accumulation of dose to surrounding organs
at risk. To reduce toxicity, focal therapy is warranted. With advancements in
imaging modalities, determination of the exact tumor location has become
possible, in addition to adequate exclusion of metastatic disease. Currently,
the radiotherapy department in the University Medical Centre Utrecht has a 1.5T
magnetic resonance imaging (MRI) high-dose-rate brachytherapy (HDR-BT)
facility, allowing for optimal visualization during treatment. At the
Haaglanden Medical Center in the Hague, an operating theatre is available for a
similar brachytherapy implant procedure. With these facilities, focal treatment
is possible by inserting catheters into the tumor under MRI-guidance. Due to
the steep dose fall-off in brachytherapy, low radiation doses will be expected
in the surrounding healthy tissues, while maximum dose can be applied to the
tumor. Therefore, less toxicity to the organs at risk is expected, while tumor
control is maintained. In earlier studies, it was shown that salvage HDR-BT is
feasible. Moreover, results regarding toxicity are promising. Therefore, we
expect that focal salvage MRI-guided HDR-BT will be of benefit in patients with
locally recurrent prostate cancer.
Study objective
To assess toxicity of MRI-guided focal salvage high-dose-rate brachytherapy
(HDR-BT) in patients with locally recurrent prostate cancer. Secondary
objectives are quality of life, biochemical disease free survival, dose
restrictions, technical aspects (catheter shifts) and predictive factors for
tumor control.
Study design
Multicenter prospective phase II single-arm study.
Intervention
MRI-guided focal salvage HDR-BT in a single fraction of 19 Gray (Gy).
Study burden and risks
In order to keep toxicity to a minimum, strict dose constraints to the organs
at risk (urethra, bladder and rectum) will be applied using state of the art
planning procedures prior to focal salvage HDR-BT. If the dose to the organs at
risk is exceeded, the dose to the planning target volume (PTV) will be
decreased. Within our UMCU feasibility study on focal salvage HDR-BT (METC
number 12-622), so far toxicity has been limited to one patient experiencing
grade 3 genitourinary toxicity (<5%). Furthermore, hormonal treatment may be
prevented or delayed in the future, thereby preventing hormone induced
toxicity. Moreover, the postponement of castration resistance can potentially
increase survival. To investigate quality of life, validated questionnaires
will be used. The use of MRI scans will induce no additional health risks.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years;
- Recurrence >=2 years after primary radiotherapy treatment (low-dose-rate
brachytherapy of external beam radiation therapy);
- Prostate Specific Antigen (PSA) at time of salvage <=20 ng/ml;
- Prostate Specific Antigen (PSA) doubling time >=9 months;
- Stage <=T3b tumor (extra prostatic extension into the seminal vesicle(s));
- Acceptable toxicity of primary radiation treatment (International Prostate
Symptom Score (IPSS)<15);
- Concordance between PSMA-PET/CT and mp-MRI;
- Tumor location technically feasible for brachytherapy;
- Karnofsky score >=70;
- Written informed consent;
- Fit for spinal anesthesia.
Exclusion criteria
- Distant metastases;
- Previous pelvic radiotherapy for another malignancy;
- Prior prostate treatment(s) like a recent transurethral resection of the
prostate (TURP) (<6 months before focal salvage HDR treatment), HIFU or
cryosurgery, except for radiotherapy;
- Contraindications for MRI;
- Severe toxicity from primary radiation treatment (IPSS >15);
- Anticoagulant administration continuously required, except for platelet
aggregation inhibitors (for example Ascal/Persantin).
Design
Recruitment
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 | NL63728.041.17 |
| Other | NL6827 |