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Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy

Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04718987
Acronym
PRIAPUS
Enrollment
10
Registered
2021-01-22
Start date
2021-06-01
Completion date
2025-12-31
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Brachytherapy, Radiation, Low Dose Rate

Brief summary

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.

Detailed description

Low dose rate (LDR) brachytherapy is an excellent treatment strategy for patients with prostate confined cancers, achieving high curative rates. However, LDR brachytherapy has been linked with long-term erectile dysfunction (ED), with a broad range of reported incidence in the literature. The pathophysiology associated with ED is complex and variable among different prostate cancer treatment strategies. In the post radical prostatectomy (RP) setting, ED is usually an immediate phenomenon and associated with neuropraxia caused by trauma and inflammation (Nandipati 2006). On the contrary, external beam radiotherapy (EBRT) related ED frequently occurs between 6-24 months and is believed to be vasculogenic in nature and caused by veno-vascular luminal occlusion (Mulhall et al. 2005) that culminates into fibrosis of the corporal tissue. In the post brachytherapy setting, seems plausible that a combination of both nerve and vascular damage are involved in the ED pathogenesis as erectile scores seem to reduce in the first months post implant (likely due to trauma) followed by a subsequent recovery and then, a gradual decline (Mabjeesh 2005). Despite a more complex pathophysiology, rates of ED post LDR brachytherapy seem to be lower than post EBRT or RP treatment (Crook 2010, Putora 2015). This may be associated with a significantly lower degree of trauma to the surrounding healthy tissue compared with trauma caused by RP and a more conformal dose around the prostate when contrasted with EBRT. In this regard, brachytherapy delivers a lesser dose to important structures previously correlated with an erectile function such as the internal pudendal artery (IPA), penile bulb, corpus cavernosum and possibly the neurovascular bundle. Currently, some strategies have been developed in an attempt to minimize ED post radiotherapy. In the POTEN-C clinical trial (NCT03525262), 120 patients are being randomized to stereotactic ablative radiotherapy with or without neurovascular sparing (neurovascular bundle, IPA and penile bulb/corpus carvenosum) with ED as the primary endpoint. Although the concept is intriguing, LDR brachytherapy has superior dose conformality and hence, a better chance to reduce radiation dose to the surrounding structures involved in the erectile function while still effectively treating the prostate cancer.

Interventions

RADIATIONLow dose rate (LDR) brachytherapy

Low dose rate (LDR) brachytherapy is a type of radiation treatment where doctor places the radioactive implants (seeds) inside patient's prostate gland and these seeds emits low dose radiation over a certain period of time. During low-dose-rate brachytherapy, a continuous low dose of radiation is released over time -from several hours to several days.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective, single-arm clinical trial to enroll a total of 10 low- or favourable intermediate-risk prostate cancer patients.

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.1 month after interventionAcceptable 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

MeasureTime frameDescription
Number of patient with preserved erectile function Erectile Function (IIEF) >= 18)1, 6, 12, 18, 24, 36, 48, 60 months post interventionThe 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
Post-procedure PSA dynamic6, 12, 18, 24, 36, 48, 60 months post interventionPSA curve post procedure
Acute and long-term GU and GI toxicity1, 6, 12, 18, 24, 36, 48, 60 months post interventionEvaluate 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.
Biochemical failure1, 6, 12, 18, 24, 36, 48, 60 months post interventionBiochemical failure will be assessed according to the Phoenix criteria (nadir + 2.0ng/mL)
Local recurrenceUntil study completion with 5 years of follow upTo assess the rate of biopsy-proven local recurrence

Countries

Canada

Contacts

Primary ContactRobin Sachdeva, PhD
robin.sachdeva@lhsc.on.ca519-685-8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026