Partial Prostate Salvage High Dose Rate Brachytherapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    15
  • sponsor
    British Columbia Cancer Agency
Updated on 23 January 2021
ct scan
platelet count
androgens
antiandrogen therapy
androgen suppression
bone scan
brachytherapy
external beam radiation therapy

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.

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.

Details
Condition Recurrent Prostate Cancer
Treatment HDR partial prostate brachytherapy
Clinical Study IdentifierNCT03246802
SponsorBritish Columbia Cancer Agency
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
> 3 year interval since EBRT
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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note