Prostate Cancer Clinical Trial
— PRIAPUSOfficial title:
Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy
NCT number | NCT04718987 |
Other study ID # | PRIAPUS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2025 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Chasseray 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 (125)I 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. — View Citation
Crook 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. — View Citation
Mabjeesh 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. — View Citation
Mulhall 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. — View Citation
Putora 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. — View Citation
Sun 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant. | Acceptable dose distribution is defined as: Target volume (Prostate, excluding a 5 mm expansion of the Neurovascular bundle) D90 = 140 Gy Contralateral neurovascular bundle median dose = 50 Gy Prostatic bulb D10 dose = 50 Gy (Chasseray 2019) Urethra D30 < 130% of the prescription dose |
1 month after intervention | |
Secondary | Number of patient with preserved erectile function Erectile Function (IIEF) >= 18) | The IIEF classifies the severity of ED into five categories stratified by score No ED.26-30 Mild.22-25 Mild to moderate.17-21 Moderate.11-16 Severe.6-10 |
1, 6, 12, 18, 24, 36, 48, 60 months post intervention | |
Secondary | Post-procedure PSA dynamic | PSA curve post procedure | 6, 12, 18, 24, 36, 48, 60 months post intervention | |
Secondary | Acute and long-term GU and GI toxicity | Evaluate acute and long-term G3 or larger toxicity based on NCI-CTCAE 5.0 score system. Grade 1 to Grade 5. Higher the grade more severe is the toxicity. | 1, 6, 12, 18, 24, 36, 48, 60 months post intervention | |
Secondary | Biochemical failure | Biochemical failure will be assessed according to the Phoenix criteria (nadir + 2.0ng/mL) | 1, 6, 12, 18, 24, 36, 48, 60 months post intervention | |
Secondary | Local recurrence | To assess the rate of biopsy-proven local recurrence | Until study completion with 5 years of follow up |
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