This combined phase I and II study is proposed to find the appropriate save dose level of one-fraction HDR-BT as monotherapy for low-risk PCa (phase I) and to evaluate the toxicity and clinical outcome of this dose level (phase II). In phase I,…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In phase I the incidence of acute (up to 3 months after treatment)
gastrointestinal (GI) and genitourinary (GU) toxicity grade 3 or higher will be
determined for each dose level. In phase II the acute and one-year late
toxicity incidences will be evaluated as primary endpoints.
Secondary outcome
Secondary endpoints will be biochemical recurrence rate, disease specific
survival and quality of life.
Background summary
Hypofractionation of radiotherapy prostate cancer (PCa) treatment regimens have
shown good results. High-dose-rate brachytherapy (HDR-BT) as monotherapy is one
of the most used hypofractionated treatments for PCa with several fractions in
a short time period. Early experiences with a single fraction regimen are
primitive but seem promising. However, the appropriate dose level and the
toxicities are not yet known and not investigated. Changing a multi-fraction
scheme into a one-fraction scheme will improve patient comfort during
treatment, improve treatment accuracy and save time, costs and human resources.
A one-fraction scheme is also expected to decrease toxicity rates with similar
clinical outcome as the standard treatment scheme. However, there is no clear
evidence which dose level will result in best outcome without increasing
toxicity.
Study objective
This combined phase I and II study is proposed to find the appropriate save
dose level of one-fraction HDR-BT as monotherapy for low-risk PCa (phase I) and
to evaluate the toxicity and clinical outcome of this dose level (phase II). In
phase I, acute toxicity of three dose levels will be assessed to find the
highest save dose level without excessive toxicity. Phase II will test the
feasibility of this recommended dose level (RDL) in a larger patient population
and with longer follow-up.
Study design
This study is designed as a prospective, nonrandomized combined phase I and
phase II study in which three consecutive groups of patients with low-risk PCa
will be treated with three different dose levels using single fraction HDR-BT
monotherapy. In phase I, a 5+5 dose escalation scheme will be used to establish
the RDL and, depending on the findings, 20-30 patients will be included. For
phase II 45 will be included in a minimax Simon 2-stage design, including the
10 patients from phase I treated with the RDL. An interim analysis will be
performed after 23 patients.
Intervention
All patients will be treated with HDR-BT in a single fraction. In phase I
fraction doses will be 19, 19.5 and 20 Gy for consecutive groups. Phase II will
continue with the RDL of phase I.
Study burden and risks
Compared to the standard monotherapy regimen, only treatment time and dose
level will be different. Total dose will be delivered in one day instead of two
days, which reduces patient burden. The total dose given is lower than the dose
given in current practice. However, the highest save dose level is not
confirmed and toxicity and clinical outcome of this one-fraction scheme are
still unclear and subject of this study. During follow-up the schedule of
visits will be kept strictly according to normal clinical practice. Follow-up
also includes the use of patient self-assessment questionnaires which will be
sent according to the standard schedule to assess toxicity and quality of life.
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Listed location countries
Age
Inclusion criteria
Men aged 18-80 years
Histological confirmation of prostate adenocarcinoma
Gleason score * 7
Clinical stage T1c-T2a, N0-X, M0
PSA * 15 ng/ml
WHO performance status 0-2
Prostate volume * 50 ml
IPSS score * 12
Maximum urinary flow rate * 15 ml/s at uroflowmetry and residual volume of < 100 ml
Ability and willingness to comply with follow-up and completion of questionnaires
Written informed consent.
Exclusion criteria
Previous malignancy within the last 5 years, except basal cell carcinoma or squamous cell carcinoma of the skin
In case of Gleason score 7: more than 3 positive biopsies
Prior pelvic radiotherapy
Prior androgen deprivation therapy (including androgen agonists and antagonists)
Any prior active treatment for prostate cancer (Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria)
Life expectancy <5 years
Prior TURP (transurethral resection of the prostate)
Co-morbidity preventing general or spinal anesthesia
Hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease or significant urinary symptoms
Anticoagulation with coumarins or bleeding tendency making brachytherapy unsafe in the opinion of the clinician
Medical condition or implant that prohibits MRI imaging
Participation in another concurrent treatment protocol.
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 | NL55981.078.15 |