Clinical trial · Interventional
Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy
NCT04718987CI-TRIAL-00058521PRIAPUSunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop and evaluate a Magnetic Resonance (MR) fusion 3D Ultrasound (US) guided Low dose rate (LDR) brachytherapy technique that significantly spares prostatic neurovascular bundles (a bundle of nerves and vessels that run beside the prostate) and penile bulb (base of the penis), while still trying to effectively treat the prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose rate (LDR) brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate Cancer Patients
- description
- Low- or favourable intermediate-risk prostate cancer patients
- interventionNames
- Radiation: Low dose rate (LDR) brachytherapy
Primary outcomes (1)
- measure
- Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.
- timeFrame
- 1 month after intervention
- description
- Acceptable dose distribution is defined as: 1. Target volume (Prostate, excluding a 5 mm expansion of the Neurovascular bundle) D90 ≥ 140 Gy 2. Contralateral neurovascular bundle median dose ≤ 50 Gy 3. Prostatic bulb D10 dose ≤ 50 Gy (Chasseray 2019) 4. Urethra D30 \< 130% of the prescription dose
Secondary outcomes (5)
- measure
- Number of patient with preserved erectile function Erectile Function (IIEF) >= 18)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-confirmed adenocarcinoma of the prostate * NCCN-defined low- or favourable intermediate-risk prostate cancer patients * All pathological cores confined to one lobe of the prostate (minimum of 12 cores sampled), unless a recent multiparametric prostate MR-scan (mpMR) (with \< 6 months from the enrollment date) indicates a dominant intra-prostatic lesion (DIL) located at the prostatic lobe where a higher number of cores and Gleason score was found positive. PIRADS v2 score 3-5 lesions are considered DILs. * No or mild erectile function impairment (score ≥18 in International Index of Erectile Function- 5 \[IIEF-5\] without PDE-5 inhibitor assistance) * Sexually active * No contraindications to prostate LDR brachytherapy Exclusion Criteria: * Core positivity in both lobes of the prostate with no DIL detected on mpMR * mpMR suggesting presence of DILs in both lobes of the prostate * Contraindications to receiving a MR-scan * Medically unfit for general and/or spinal anesthesia * IPSS score \> 15 * Inflammatory bowel disease * Prior abdominal-perineal resection * Presence of distant metastases and/or nodal disease * Older than 75 years of age * Use of cytoreductive prostate treatment (including 5 alpha-reductase inhibitors) * NCCN-defined unfavourable intermediate or high-risk prostate cancer * Signs of extra-capsular extension or seminal vesicle involvement on MR-scan * Prior TURP * \> 3mm of median lobe protrusion to bladder measured in mpMR (Roeloffzen 2011) * Prior RT to the pelvis * Significant artifact on MR-Scan (e.g. caused by hip prosthesis)
References
Publications (6)
- BACKGROUNDMulhall J, Ahmed A, Parker M, Mohideen N. The hemodynamics of erectile dysfunction following external beam radiation for prostate cancer. J Sex Med. 2005 May;2(3):432-7. doi: 10.1111/j.1743-6109.2005.20362.x. PMID 16422876
- BACKGROUNDMabjeesh N, Chen J, Beri A, Stenger A, Matzkin H. Sexual function after permanent 125I-brachytherapy for prostate cancer. Int J Impot Res. 2005 Jan-Feb;17(1):96-101. doi: 10.1038/sj.ijir.3901271. PMID 15510186
- BACKGROUNDPutora PM, Engeler D, Haile SR, Graf N, Buchauer K, Schmid HP, Plasswilm L. Erectile function following brachytherapy, external beam radiotherapy, or radical prostatectomy in prostate cancer patients. Strahlenther Onkol. 2016 Mar;192(3):182-9. doi: 10.1007/s00066-015-0928-x. Epub 2015 Dec 28. PMID 26713323
- BACKGROUNDChasseray M, Dissaux G, Bourbonne V, Boussion N, Goasduff G, Malloreau J, Malhaire JP, Fournier G, Tissot V, Pradier O, Valeri A, Schick U. Dose to the penile bulb and individual patient anatomy are predictive of erectile dysfunction in men treated with 125I low dose rate brachytherapy for localized prostate cancer. Acta Oncol. 2019 Jul;58(7):1029-1035. doi: 10.1080/0284186X.2019.1574981. Epub 2019 Feb 14. PMID 30761939
- BACKGROUNDSun Y, Qiu W, Yuan J, Romagnoli C, Fenster A. Three-dimensional nonrigid landmark-based magnetic resonance to transrectal ultrasound registration for image-guided prostate biopsy. J Med Imaging (Bellingham). 2015 Apr;2(2):025002. doi: 10.1117/1.JMI.2.2.025002. Epub 2015 Jun 24. PMID 26158111
- BACKGROUNDCrook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13. PMID 21149658