COMBINATION_PRODUCT
SBRT combined with ADT
SBRT combined with Zoladex
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
Status
Not yet recruiting
Phase
Not applicable
Enrollment
130
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 10, 2026
Study start
Mar 16, 2026
Primary completion
Mar 16, 2028
Study completion
Dec 31, 2029
Results posted
Not reported
Registry updated
Mar 10, 2026
Outcomes
What the study measures.
Primary outcomes
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)
Secondary outcomes
Proportion of patients with clinically significant (moderate to severe) erectile dysfunction
Time frame · Baseline, 3, 9, 15, and 24 months
Measurement Tool: IIEF-5 (SHIM) Unit of Measure: Percentage (%) of patients with IIEF-5 score ≤ 11
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
Measurement Tool: EPIC-26 Questionnaire - Sexual Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better sexual function)
Hormonal Domain Score of the Expanded Prostate Cancer Index Composite (EPIC-26)
Time frame · Baseline, 3, 9, 15, and 24 months
Measurement Tool: EPIC-26 Questionnaire - Hormonal Domain Unit of Measure: Standardized domain score (0-100 scale; higher scores indicate better hormonal function)
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
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)
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)
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)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- MALE
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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).
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Manitoba Prostate Centre
Winnipeg, Manitoba, Canada
Publications
Results and literature.
PMID 17099194 ↗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.PMID 25846097 ↗Balachandran 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.PMID 37965376 ↗Kennady 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.PMID 25530370 ↗Skolarus 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.PMID 31216252 ↗Laviana 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.PMID 18929686 ↗Harris 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.PMID 31809979 ↗Alayed 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.PMID 26663514 ↗Matsushima 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.PMID 21934053 ↗Alemozaffar 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.PMID 23868003 ↗Wheelwright 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.PMID 35305936 ↗Sholklapper 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.PMID 17666037 ↗Ramanathan 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.
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