NCT03830788 Erectile Dysfunction in Good Prognosis Prostate Cancer : Comparison Between Brachytherapy and Stereotactic Body Radiotherapy
| NCT ID | NCT03830788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Center Eugene Marquis |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2019-10-04 |
| Primary Completion | 2030-04-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2019-10-04 with a primary completion date of 2030-04-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, 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.
Eligibility Criteria
Main 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, Main 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
Contact & Investigator
Renaud De Crevoisier, PR
PRINCIPAL INVESTIGATOR
Centre Eugène Marquis
Frequently Asked Questions
Who can join the NCT03830788 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03830788 currently recruiting?
Yes, NCT03830788 is actively recruiting participants. Contact the research team at m.gestin@rennes.unicancer.fr for enrollment information.
Where is the NCT03830788 trial being conducted?
This trial is being conducted at Albi, France, Angers, France, Bordeaux, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT03830788 clinical trial?
NCT03830788 is sponsored by Center Eugene Marquis. The principal investigator is Renaud De Crevoisier, PR at Centre Eugène Marquis. The trial plans to enroll 240 participants.
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