Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Low- or favourable intermediate-risk prostate cancer patients

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.

Low dose rate (LDR) brachytherapy

Robin Sachdeva, PhD

Lucas Mendez, MD, PhD

Lucas Mendez, MD

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.

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.

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

Male only because this study trying to preserve the Penis erection in patients undergoing Radiation treatment for their prostate cancer.

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

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

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

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.

Biochemical failure will be assessed according to the Phoenix criteria (nadir + 2.0ng/mL)

To assess the rate of biopsy-proven local recurrence

Lawson Health Research Institute

Rare Diseases

Carcinoma

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Acute Graft Versus Host Disease

HIgh Dose Rate Vs Low DOse Rate Brachytherapy

Shyamkishore J Shrivastava, MD, DNB (RT)

Radiation therapy still remains mainstay of treatment for patients with carcinoma cervix in advanced stages. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is the time-tested modality of brachytherapy with sound radiobiological bases. But high dose rate brachytherapy is a relatively new alternative. In low dose rate brachytherapy the staff receives some radiation while in the high dose rate brachytherapy procedure complete protection to staff can be achieved as the treatment is done with remote afterloading technique. The high dose rate brachytherapy is possible as Out Patient Department procedure. Few clinical trials have proven the feasibility and efficacy of high dose rate brachytherapy in carcinoma of cervix. However, there is no concrete evidence especially in developing countries for the change of practice to HDR brachytherapy. Hence, at Tata Memorial Hospital with an aim to assess the efficacy, feasibility, early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy we propose this study.

Carcinoma cervix is the most common malignancy in Indian women and constitutes approximately 27% of all cancers as recorded in the annual report of Hospital based cancer registry 1991. Carcinoma of cervix forms one of the leading causes for death and disability due to cancers in India.

Nearly 80% of the patients with carcinoma cervix present in advanced stages. Despite the advances in conventional modalities the five-year survival is 26% and 43% for stage IIIB and stage IIB respectively. In developing countries the socio-economic problems, illiteracy, late presentation and irregular follow-up resulting in early locoregional and distant failures further compound the problem.

Radiation therapy still remains the important modality of treatment for patients with carcinoma cervix in advanced stages. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary treatment is the time-tested modality of brachytherapy for carcinoma of cervix having sound radiobiological bases. But high dose rate brachytherapy is a relatively new method. In low dose rate brachytherapy the staff receives some radiation while in the high dose rate brachytherapy procedure complete protection to staff can be achieved as the treatment is done with remote afterloading technique. The high dose rate brachytherapy is possible as OPD procedure. Various clinical trials have proved the feasibility and efficacy of high dose rate brachytherapy for carcinoma of cervix. At Tata Memorial Hospital we advocate a study to assess the efficacy, feasibility, early and late complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy	NCT04718987	Prostate Cancer	Low dose rate (...	18 Years - 75 Years	Lawson Health Research Institute
High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix	NCT00193830	Cancer of Cervi... Cervical Cancer Cancer of the C... Cervix Cancer	HIgh Dose Rate ...	18 Years - 65 Years	Tata Memorial Hospital
High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix	NCT00193830	Cancer of Cervi... Cervical Cancer Cancer of the C... Cervix Cancer	HIgh Dose Rate ...	18 Years - 65 Years	Tata Memorial Hospital

Spots Global Cancer Trial Database for low dose rate (ldr) brachytherapy