Prostate Cancer (Adenocarcinoma)PRIAPUS-PCaNCT07460726
PRIAPUS-PCa Study: Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) Impact on Sexual Function on Men With Unfavorable Intermediate Risk Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma) and Erectile Abnormalities, run by CancerCare Manitoba at 1 site in Canada.
Trial summary
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Erectile Abnormalities, Sexual Dysfunction Male
- What is being tested?
- SBRT combined with ADT
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2026to 31 Dec 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Favorable and unfavorable intermediate risk prostate cancer patients
Who may be able to join
- Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network [NCCN] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
- Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
- Baseline sexual function assessment available (International Index of Erectile Function [IIEF-5, also known as SHIM] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Written informed consent to participate.
Who cannot join
- Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
- Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
- Hypogonadism at presentation (baseline testosterone below normal range)
- Contraindications to SBRT or ADT
- Metastatic disease, second malignancy, or previous malignancies.
- Benign or malignant penile diseases.
Show all 9Show fewer
- Use of medications altering ejaculation (e.g., 5-alpha reductase inhibitors)
- Psychiatric conditions affecting questionnaire completion or QoL assessment
- Severe comorbidities affecting QoL assessments (e.g., advanced cardiovascular disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zoe Ignacio, RN, BN (BScN) contact
Canada1 site
Manitoba Prostate Centre
Winnipeg, Manitoba, R3E 0V9
Zoe Ignacio, RN, BN (BScN), 1-204-787-2955, ccmb_manitoba_prostate_centre_research@cancercare.mb.ca
Vibhay Pareek, MD, FRCPC
About this study
Official title: A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.
Read the detailed description
This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.
- Being tested
- SBRT combined with ADT
- Keywords
- Prostate cancer, sexual function, SBRT, ADT
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT combined with ADTCombination product
SBRT combined with Zoladex
| Study group | Role | What they receive |
|---|---|---|
| Observational | Prostate cancer patients receiving SBRT and ADT Receives: Combination Product: SBRT combined with ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.
Outcome Measure Title:
Change in Erectile Function Score as Measured by the International Index of Erectile Function-5 (IIEF-5 / SHIM)
Measurement Tool:
International Index of Erectile Function-5 (IIEF-5, also known as SHIM)
Unit of Measure:
Total IIEF-5 score (range 1-25; higher scores indicate better erectile function)
Derived Unit:
Change in IIEF-5 score from baseline to 24 months (continuous variable, points)
Measured: Baseline, 3, 9, 15, and 24 months post-SBRT
Secondary outcomes (5)
Proportion of patients with clinically significant (moderate to severe) erectile dysfunction
Measurement Tool:
IIEF-5 (SHIM)
Unit of Measure:
Percentage (%) of patients with IIEF-5 score ≤ 11
Measured: Baseline, 3, 9, 15, and 24 months
Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score
Measurement Tool:
EPIC-26 Questionnaire - Sexual Domain
Unit of Measure:
Standardized domain score (0-100 scale; higher scores indicate better sexual function)
Measured: Baseline, 3, 9, 15, and 24 months
Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)
Measurement Tool:
EPIC-26 Questionnaire - Hormonal Domain
Unit of Measure:
Standardized domain score (0-100 scale; higher scores indicate better hormonal function)
Measured: Baseline, 3, 9, 15, and 24 months
Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)
Measurement Tool:
Male Sexual Health Questionnaire - Ejaculation Scale (ES-8)
Unit of Measure:
Total ES-8 score (range 3-40; higher scores indicate worse ejaculatory function)
Measured: Baseline, 3, 9, 15, and 24 months
Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14
Measurement Tool:
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Elderly Module (EORTC QLQ-ELD14)
Unit of Measure:
Standardized subscale scores (0-100 scale):
Functional scales (higher = better functioning)
Symptom scales (higher = greater symptom burden)
Measured: Baseline, 3, 9, 15, and 24 months (for patients >70 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion16 Mar 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- TerSera Therapeutics LLC
- Responsible party
- Principal investigator, Dr. Vibhay Pareek, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460726
- Sponsor's protocol ID
- 1219
- Acronym
- PRIAPUS-PCa
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361.
PubMed 17099194Balachandran VP, Gonen M, Smith JJ, DeMatteo RP. Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7.
PubMed 25846097Kennady EH, Bryk DJ, Ali MM, Ratcliffe SJ, Mallawaarachchi IV, Ostad BJ, Beano HM, Ballantyne CC, Krzastek SC, Clements MB, Gray ML, Rapp DE, Ortiz NM, Smith RP. Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial. Sex Med. 2023 Nov 11;11(5):qfad053. doi: 10.1093/sexmed/qfad053. eCollection 2023 Oct.
PubMed 37965376Skolarus TA, Dunn RL, Sanda MG, Chang P, Greenfield TK, Litwin MS, Wei JT; PROSTQA Consortium. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. 2015 Jan;85(1):101-5. doi: 10.1016/j.urology.2014.08.044.
PubMed 25530370Laviana AA, Hernandez A, Huang LC, Zhao Z, Koyama T, Conwill R, Hoffman K, Feurer ID, Goodman M, Hamilton AS, Wu XC, Paddock LE, Stroup A, Cooperberg MR, Hashibe M, O'Neil BB, Kaplan SH, Greenfield S, Penson DF, Barocas DA. Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes? J Urol. 2019 Dec;202(6):1150-1158. doi: 10.1097/JU.0000000000000392. Epub 2019 Jun 19.
PubMed 31216252Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Alayed Y, Davidson M, Quon H, Cheung P, Chu W, Chung HT, Vesprini D, Ong A, Chowdhury A, Liu SK, Panjwani D, Helou J, Musunuru HB, Pang G, Korol R, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Commisso A, Commisso K, D'Alimonte L, Ho L, Bhounr Z, Loblaw A. Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. Radiother Oncol. 2020 Mar;144:135-140. doi: 10.1016/j.radonc.2019.11.017. Epub 2019 Dec 3.
PubMed 31809979Matsushima M, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Ohashi T, Mikami S, Miyajima A, Shigematsu N, Oya M. Erectile function status is highly associated with prostate-specific antigen bounce in localized prostate cancer patients treated with permanent prostate brachytherapy. Int J Urol. 2016 Mar;23(3):247-52. doi: 10.1111/iju.13029. Epub 2015 Dec 12.
PubMed 26663514Alemozaffar M, Regan MM, Cooperberg MR, Wei JT, Michalski JM, Sandler HM, Hembroff L, Sadetsky N, Saigal CS, Litwin MS, Klein E, Kibel AS, Hamstra DA, Pisters LL, Kuban DA, Kaplan ID, Wood DP, Ciezki J, Dunn RL, Carroll PR, Sanda MG. Prediction of erectile function following treatment for prostate cancer. JAMA. 2011 Sep 21;306(11):1205-14. doi: 10.1001/jama.2011.1333.
PubMed 21934053Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.
PubMed 23868003Sholklapper T, Creswell M, Cantalino J, Markel M, Zwart A, Danner M, Ayoob M, Yung T, Collins B, Kumar D, Aghdam N, Rubin RS, Hankins R, Suy S, Collins S. Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer. J Sex Med. 2022 May;19(5):771-780. doi: 10.1016/j.jsxm.2022.02.018. Epub 2022 Mar 17.
PubMed 35305936Ramanathan R, Mulhall J, Rao S, Leung R, Martinez Salamanca JI, Mandhani A, Tewari A. Predictive correlation between the International Index of Erectile Function (IIEF) and Sexual Health Inventory for Men (SHIM): implications for calculating a derived SHIM for clinical use. J Sex Med. 2007 Sep;4(5):1336-44. doi: 10.1111/j.1743-6109.2007.00576.x. Epub 2007 Jul 31.
PubMed 17666037Santana MJ, Feeny D, Johnson JA, McAlister FA, Kim D, Weinkauf J, Lien DC. Assessing the use of health-related quality of life measures in the routine clinical care of lung-transplant patients. Qual Life Res. 2010 Apr;19(3):371-9. doi: 10.1007/s11136-010-9599-3. Epub 2010 Feb 10.
PubMed 20146009Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027.
PubMed 12479768Ray ME, Thames HD, Levy LB, Horwitz EM, Kupelian PA, Martinez AA, Michalski JM, Pisansky TM, Shipley WU, Zelefsky MJ, Zietman AL, Kuban DA. PSA nadir predicts biochemical and distant failures after external beam radiotherapy for prostate cancer: a multi-institutional analysis. Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1140-50. doi: 10.1016/j.ijrobp.2005.07.006. Epub 2005 Sep 29.
PubMed 16198506
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Prospective Study to Investigate the Impact of Stereotactic Body Radiation Therapy (SBRT) and Androgen Deprivation Therapy (ADT) on Sexual Dysfunction in Unfavorable Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT07460726
- Acronym / sponsor ID
- PRIAPUS-PCa / 1219
- Keywords
- Prostate cancer, sexual function, SBRT, ADT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Collaborators
- TerSera Therapeutics LLC
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 16 Mar 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at how combined radiation and hormone therapy affects sexual function in men with a specific type of prostate cancer, before and after treatment.
Detailed description
This study examines how two standard combination treatment for prostate cancer - a highly targeted form of radiation called Stereotactic Body Radiation Therapy (SBRT) and a hormone-blocking treatment called Androgen Deprivation Therapy (ADT) - impact sexual function in men with unfavorable intermediate risk prostate cancer. Participants will complete study questionnaires before treatment or Baseline, and after treatment, on Month 3, 9, 15, and 24.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Combination Product: SBRT combined with ADTProstate cancer patients receiving SBRT and ADT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Favorable and unfavorable intermediate risk prostate cancer patients
Key inclusion criteria (5 listed)
- Men aged 18-80 years with biopsy-proven UIR-PCa (National Comprehensive Cancer Network [NCCN] criteria: Gleason score 7 (4+3), PSA 10-20 ng/mL, or clinical stage T2b-T2c)
- Planned treatment with SBRT (36.25-37.5 Gy in 5 fractions) and ADT (6 months)
- Baseline sexual function assessment available (International Index of Erectile Function [IIEF-5, also known as SHIM] score ≥ 12 or pre-selection erection status score of 1-3: erection insufficient for intercourse, sufficient but not optimal, or normal)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Written informed consent to participate.
Key exclusion criteria (9 listed)
- Prior pelvic radiotherapy, prostate surgery, ADT, or chemotherapy
- Pre-existing severe sexual dysfunction (IIEF-5 score < 12 or pre-selection erection status score of 0: no erection)
- Hypogonadism at presentation (baseline testosterone below normal range)
- Contraindications to SBRT or ADT
- Metastatic disease, second malignancy, or previous malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT combined with ADTSBRT combined with Zoladex | Combination product | Observational |
Primary outcome
Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score.
Time frame: Baseline, 3, 9, 15, and 24 months post-SBRT
Outcome Measure Title: Change in Erectile Function Score as Measured by the International Index of Erectile Function-5 (IIEF-5 / SHIM) Measurement Tool: International Index of Erectile Function-5 (IIEF-5, also known as SHIM) Unit of Measure: Total IIEF-5 score (range 1-25; higher scores indicate better erectile function) Derived Unit: Change in IIEF-5 score from baseline to 24 months (continuous variable, points)
5 secondary outcomes
Proportion of patients with clinically significant (moderate to severe) erectile dysfunction
Time frame: Baseline, 3, 9, 15, and 24 months
Change in sexual function, as measured by the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) sexual domain score
Time frame: Baseline, 3, 9, 15, and 24 months
Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)
Time frame: Baseline, 3, 9, 15, and 24 months
Ejaculatory Function Score as Measured by the Male Sexual Health Questionnaire - Ejaculation Scale (MSHQ-ES-8)
Time frame: Baseline, 3, 9, 15, and 24 months
Health-Related Quality of Life Score as Measured by EORTC QLQ-ELD14
Time frame: Baseline, 3, 9, 15, and 24 months (for patients >70 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 17099194Vickers AJ, Elkin EB. Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making. 2006 Nov-Dec;26(6):565-74. doi: 10.1177/0272989X06295361.
- Background: PubMed 25846097Balachandran VP, Gonen M, Smith JJ, DeMatteo RP. Nomograms in oncology: more than meets the eye. Lancet Oncol. 2015 Apr;16(4):e173-80. doi: 10.1016/S1470-2045(14)71116-7.
- Background: PubMed 37965376Kennady EH, Bryk DJ, Ali MM, Ratcliffe SJ, Mallawaarachchi IV, Ostad BJ, Beano HM, Ballantyne CC, Krzastek SC, Clements MB, Gray ML, Rapp DE, Ortiz NM, Smith RP. Low-intensity shockwave therapy improves baseline erectile function: a randomized sham-controlled crossover trial. Sex Med. 2023 Nov 11;11(5):qfad053. doi: 10.1093/sexmed/qfad053. eCollection 2023 Oct.
- Background: PubMed 25530370Skolarus TA, Dunn RL, Sanda MG, Chang P, Greenfield TK, Litwin MS, Wei JT; PROSTQA Consortium. Minimally important difference for the Expanded Prostate Cancer Index Composite Short Form. Urology. 2015 Jan;85(1):101-5. doi: 10.1016/j.urology.2014.08.044.
- Background: PubMed 31216252Laviana AA, Hernandez A, Huang LC, Zhao Z, Koyama T, Conwill R, Hoffman K, Feurer ID, Goodman M, Hamilton AS, Wu XC, Paddock LE, Stroup A, Cooperberg MR, Hashibe M, O'Neil BB, Kaplan SH, Greenfield S, Penson DF, Barocas DA. Interpretation of Domain Scores on the EPIC-How Does the Domain Score Translate into Functional Outcomes? J Urol. 2019 Dec;202(6):1150-1158. doi: 10.1097/JU.0000000000000392. Epub 2019 Jun 19.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 31809979Alayed Y, Davidson M, Quon H, Cheung P, Chu W, Chung HT, Vesprini D, Ong A, Chowdhury A, Liu SK, Panjwani D, Helou J, Musunuru HB, Pang G, Korol R, Ravi A, McCurdy B, Zhang L, Mamedov A, Deabreu A, Commisso A, Commisso K, D'Alimonte L, Ho L, Bhounr Z, Loblaw A. Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy. Radiother Oncol. 2020 Mar;144:135-140. doi: 10.1016/j.radonc.2019.11.017. Epub 2019 Dec 3.
- Background: PubMed 26663514Matsushima M, Kikuchi E, Matsumoto K, Kosaka T, Mizuno R, Ohashi T, Mikami S, Miyajima A, Shigematsu N, Oya M. Erectile function status is highly associated with prostate-specific antigen bounce in localized prostate cancer patients treated with permanent prostate brachytherapy. Int J Urol. 2016 Mar;23(3):247-52. doi: 10.1111/iju.13029. Epub 2015 Dec 12.
- Background: PubMed 21934053Alemozaffar M, Regan MM, Cooperberg MR, Wei JT, Michalski JM, Sandler HM, Hembroff L, Sadetsky N, Saigal CS, Litwin MS, Klein E, Kibel AS, Hamstra DA, Pisters LL, Kuban DA, Kaplan ID, Wood DP, Ciezki J, Dunn RL, Carroll PR, Sanda MG. Prediction of erectile function following treatment for prostate cancer. JAMA. 2011 Sep 21;306(11):1205-14. doi: 10.1001/jama.2011.1333.
- Background: PubMed 23868003Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.
- Background: PubMed 35305936Sholklapper T, Creswell M, Cantalino J, Markel M, Zwart A, Danner M, Ayoob M, Yung T, Collins B, Kumar D, Aghdam N, Rubin RS, Hankins R, Suy S, Collins S. Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer. J Sex Med. 2022 May;19(5):771-780. doi: 10.1016/j.jsxm.2022.02.018. Epub 2022 Mar 17.
- Background: PubMed 17666037Ramanathan R, Mulhall J, Rao S, Leung R, Martinez Salamanca JI, Mandhani A, Tewari A. Predictive correlation between the International Index of Erectile Function (IIEF) and Sexual Health Inventory for Men (SHIM): implications for calculating a derived SHIM for clinical use. J Sex Med. 2007 Sep;4(5):1336-44. doi: 10.1111/j.1743-6109.2007.00576.x. Epub 2007 Jul 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zoe Ignacio, RN, BN (BScN) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma) and Erectile Abnormalities, run by CancerCare Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Ignacio, RN, BN (BScN) (1-204-787-2955, ccmb_manitoba_prostate_centre_research@cancercare.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erectile dysfunction severity from baseline to 24 months, as measured by the change in International Index of Erectile Function 5-item version (IIEF-5) score. (time frame: Baseline, 3, 9, 15, and 24 months post-SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460726, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.