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This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in > 30% of men.
All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favorable prostate cancer with pubic arch interference | Experimental | Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks. |
|
| Intermediate risk prostate cancer, 6 months Degarelix | Experimental | Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network [NCCN] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be > 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | 240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| prostate volume reduction | determined by transrectal ultrasound with planimetry volume calculation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| testosterone recovery | Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juanita M Crook, MD | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbottsford Cancer Center | Abbottsford | British Columbia | Canada | |||
| Fraser Valley Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29398594 | Derived | Korzeniowski MA, Crook JM, Bowes D, Gaztanaga M, Ots A, Jazwal J, Rose J, Tetreault-Laflamme A, Pilote L, Halperin R, Kim D, Petrik D, Araujo C, Bachand F. A Phase II trial of 8 weeks of degarelix for prostate volume reduction: Efficacy and hormonal recovery. Brachytherapy. 2018 May-Jun;17(3):530-536. doi: 10.1016/j.brachy.2017.12.005. Epub 2018 Feb 2. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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| Degarelix | Drug | 240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months. |
|
| Surrey |
| British Columbia |
| Canada |
| Vancouver Cancer Center | Vancouver | British Columbia | V5Z4E6 | Canada |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |