Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy (TEMPOS)

  • STATUS
    Recruiting
  • End date
    Oct 10, 2027
  • participants needed
    240
  • sponsor
    Center Eugene Marquis
Updated on 13 March 2022
brachytherapy
adenocarcinoma
impotence
adenocarcinoma of prostate

Summary

The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, randomized-controlled medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.

Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers.

In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.

Details
Condition Prostate Cancer
Treatment Radiation by brachytherapy, Radiation by SBRT
Clinical Study IdentifierNCT03830788
SponsorCenter Eugene Marquis
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Biopsy proven prostate adenocarcinoma
Low risk prostate cancer according to d'Amico (T1-T2a and PSA <10 ng/ml, and Gleason score 6) or intermediate risk prostate cancer according d'Amico but excluding tumor with Gleason score 7 (4 + 3)
Indication of a curative treatment by brachytherapy validated in multidisciplinary consultation meeting
Patient with IIEF-6 score > 16

Exclusion Criteria

Androgen deprivation therapy
Contraindication for prostate Iodine 125 brachytherapy (Prostate volume > 50 cc, impossibility if general anesthesia)
Contraindication for Resonance Magnetic Imagery (RMI) (claustrophobia, pacemaker)
Participation to another research which could have an impact on the study treatment and the outcomes
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