Partial Prostate Salvage High Dose Rate Brachytherapy

NCT ID: NCT03246802

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2037-01-01

Brief Summary

A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.

Detailed Description

Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and repeat mpMRI at 2 years.

Conditions

Recurrent Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDR partial prostate brachytherapy

2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI

Group Type: EXPERIMENTAL

HDR partial prostate brachytherapy

Intervention Type: RADIATION

temporary radioactive implant

Interventions

HDR partial prostate brachytherapy

temporary radioactive implant

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Age >45 and Life expectancy >10 years
• Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions or LDR brachytherapy with site of recurrence in an under-dosed or untreated site
• > 3 year interval since EBRT or LDR Brachytherapy
• No late toxicity from prior EBRT ≥ grade 2
• Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml
• PSA Doubling time > 6 months
• Negative staging with CT scan of the abdomen/pelvis and bone scan (PSMA PET scan can replace CT and bone scan)
• Able to undergo multiparametric MRI with endorectal coil
• Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease
• Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)
• Willing to provide informed consent
• History and physical examination within 90 days of registration
• ECOG performance status 0-1 prior to registration
• IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).
• No prior trans urethral prostatic resection
• Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
• No history of inflammatory bowel disease or previous rectal surgery
• Suitable for procedure under anesthesia, spinal or general
• INR <2.5 and platelet count >75 x 109/L
• Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria

• Not compliant with criteria above
• Unable to give informed consent

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Juanita Crook

Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mira Keyes, MD

Role: STUDY_DIRECTOR

BCCA

Locations

BCCA Center for the Southern Interior

Kelowna, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Juanita Crook, MD

Role: CONTACT

jcrook@bccancer.bc.ca

2507123958

Facility Contacts

Juanita Crook, MD

Role: primary

jcrook@bccancer.bc.ca

250 712 3958

References

Arrayeh E, Westphalen AC, Kurhanewicz J, Roach M 3rd, Jung AJ, Carroll PR, Coakley FV. Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e787-93. doi: 10.1016/j.ijrobp.2011.11.030. Epub 2012 Feb 11.

Reference Type: BACKGROUND

PMID: 22331003 (View on PubMed)

Banerjee R, Park SJ, Anderson E, Demanes DJ, Wang J, Kamrava M. From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis. Brachytherapy. 2015 May-Jun;14(3):366-72. doi: 10.1016/j.brachy.2014.12.007. Epub 2015 Feb 10.

Reference Type: BACKGROUND

PMID: 25680768 (View on PubMed)

Crook J, Ots A, Gaztanaga M, Schmid M, Araujo C, Hilts M, Batchelar D, Parker B, Bachand F, Milette MP. Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion. Brachytherapy. 2014 Sep-Oct;13(5):433-41. doi: 10.1016/j.brachy.2014.05.006. Epub 2014 Jun 20.

Reference Type: BACKGROUND

PMID: 24958556 (View on PubMed)

Da Rosa MR, Milot L, Sugar L, Vesprini D, Chung H, Loblaw A, Pond GR, Klotz L, Haider MA. A prospective comparison of MRI-US fused targeted biopsy versus systematic ultrasound-guided biopsy for detecting clinically significant prostate cancer in patients on active surveillance. J Magn Reson Imaging. 2015 Jan;41(1):220-5. doi: 10.1002/jmri.24710. Epub 2014 Jul 21.

Reference Type: BACKGROUND

PMID: 25044935 (View on PubMed)

Mason J, Al-Qaisieh B, Bownes P, Thwaites D, Henry A. Dosimetry modeling for focal high-dose-rate prostate brachytherapy. Brachytherapy. 2014 Nov-Dec;13(6):611-7. doi: 10.1016/j.brachy.2014.06.007. Epub 2014 Jul 29.

Reference Type: BACKGROUND

PMID: 25085456 (View on PubMed)

Rose JN, Crook JM, Pickles T, Keyes M, Morris WJ. Salvage low-dose-rate permanent seed brachytherapy for locally recurrent prostate cancer: Association between dose and late toxicity. Brachytherapy. 2015 May-Jun;14(3):342-9. doi: 10.1016/j.brachy.2015.01.002. Epub 2015 Feb 26.

Reference Type: BACKGROUND

PMID: 25727178 (View on PubMed)

Other Identifiers

H17-01641

Identifier Type: -

Identifier Source: org_study_id