Metastatic Castration-resistant Prostate CancerPhase 3OPTION-DDRNCT06439225
Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
A Phase 3 study testing Docetaxel and Carboplatin in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Prostate Cancer, run by Canadian Cancer Trials Group at 14 sites in Canada.
Trial summary
The usual approach for most patients who are not in a study is treatment with docetaxel. This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach? This study is being done to find out if this approach is better… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- Docetaxel and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 14 sitesCanada
- Study dates
- 30 Dec 2024to 31 Mar 2030
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary
- Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required.
- Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows:
- Longest of one of the following:
- Two weeks for oral therapies (such as abiraterone, apalutamide, enzalutamide, darolutamide and olaparib)
- Standard cycle of standard IV or IM therapies (such as radium 223 or Lu-177-PSMA-617
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- 2 weeks, 5 half lives, or standard cycle length (whichever is longer) for investigational agents
- Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred
- Prior external beam radiation is permitted provided a minimum of 7 days have elapsed between the last dose of radiation and date of enrollment
- Radiologically documented presence of metastatic disease within 28 days prior to randomization
- Disease progression after ARPI therapy as assessed by the investigator with at least one of the following:
- PSA progression with a minimum of two rising PSA values at least 1 week apart, at least 25% and 2ug/L above baseline/nadir.
- Radiographic progression of soft tissue disease by RECIST 1.1 criteria or bone metastases by PCWG3 criteria.
- Medical or surgical castration with serum testosterone levels <50ng/dL or <1.7mmol/L
- Qualifying Tier I or Tier II (clinically significant/likely clinically significant or pathogenic / likely pathogenic) germline or somatic alterations involving one or more of the following DDR genes: BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Monoallelic gene deletions in isolation will not be eligible.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Participants must have adequate organ and marrow function measured within 14 days prior to enrolment
- Life expectancy > 12 weeks.
- If the participant and the participant's partner are of childbearing potential, they must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 6 months after the last dose of study drug.
- Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and health utility questionnaires in either English or French
- Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate.
- Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days after participant enrolment.
Who cannot join
- Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) or prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) at any time for the treatment of prostate cancer with the exception of docetaxel for mCSPCor adjuvant therapy after curative intent treatment for localized prostate cancer, as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. If the participant received prior platinum or taxane chemotherapy for other cancers, then please contact the CCTG office to discuss this further with the trial team.
- Active anticancer systemic therapy or investigational agents within 14 days of randomization.
- Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants with myelodysplastic syndrome/acute myeloid leukemia.
- Malignancy within the previous 2-years with a > 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer.
- Participants with known symptomatic brain metastasis. However, participants with asymptomatic, treated brain metastases that have been stable for at least 12 weeks are eligible for study entry.
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- Participants with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic.
- Presence of a condition or situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with participation in the study.
- Live attenuated vaccination administered within 30 days prior to randomization.
- For patients with known immunodeficiency virus (HIV) infection, the HIV viral load must be undetectable on effective anti-retroviral therapy within 6 months of enrollment.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Unable to obtain provincial reimbursement of carboplatin and docetaxel
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Canada14 sites, 14 recruiting
- Recruiting
William Osler Health System
Brampton, Ontario, L6R 3J7
Marco Iafolla
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Steven M Yip, 604 877-6000
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Michael Kolinsky, 780 432-8762
- Recruiting
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, N2G 1G3
Anupam Batra
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
Lilian Hanna, 519 685-8600
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Zineb Hamilou, 514 890-8000 ext. 20688
- Recruiting
The Jewish General Hospital
Montreal, Quebec, H3T 1E2
April Rose
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Michael Ong, 613 737-7700 ext. 75051
- Recruiting
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Québec, Quebec, G1J 1Z4
Eric Levesque, 418 525-4444
- Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Osama Souied, 306 766-2691
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Nayyer Iqbal, 306 655-2710
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Daniel Khalaf, 416 480-4617
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Di (Maria) Jiang, 647 993-0448
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia, V5Z 4E6
Corinne Maurice Dror, 604 877-6000 ext. 4634
About this study
Official title: A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
The usual approach for most patients who are not in a study is treatment with docetaxel.
This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach?
This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.
Read the detailed description
If taking part in this study, the patient will either get docetaxel, or carboplatin in addition to docetaxel. In both cases, the cancer will be monitored by CT scans and bone scans every 9 weeks, and blood tests every 3 weeks. Study treatments, scans, and tests will continue until the disease gets worse.
After finishing study treatment, even if treatment is stopped before the disease gets worse, the study doctor will continue to follow patients condition, watch for side effects and keep track of the health of the patient. If treatment is stopped before the disease got worse, patients will be asked to continue getting CT scans and bone scans every 9 weeks, and blood tests every 3 weeks, until the disease worsens. If the disease gets worse while receiving treatment, or after treatment is stopped, the patient will be contacted by phone every 3 months for the rest of their life to monitor their status. Patients may be seen more often if the study doctor thinks it is necessary.
- Being tested
- Docetaxel, Carboplatin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75mg/m2 q21 days
CarboplatinDrug
AUC5 q21 days
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Carboplatin + Docetaxel | Experimental | Not described Receives: Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 5.25 years
Secondary outcomes (9)
To compare the two treatment arms with respect to PSA response
Defined as a reduction in PSA from baseline by 50%
Measured: 5.25 years
To compare the two treatment arms with respect to progression free survival
as defined by PCWG3 and RECIST 1.1
Measured: 5.25 years
To compare the two treatment arms with respect to time to next systemic therapy
Measured: 5.25 years
To compare the two treatment arms with respect to time to number and severity of adverse events
Utilizing CTCAE version 5.0
Measured: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-P questionnaire
Measured: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-Taxane questionnaire
Measured: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by BPI-SF questionnaire
Measured: 5.25 years
Economic Evaluation of healthcare utilization
Health system resources will be identified as, but not limited to, clinic visits, treatments (radiation, surgery, medication), physician encounters, hospitalizations related to treatment and complications, emergent visits and diagnostics.
Measured: 5.25 years
Economic Evaluation of health utilities measured by Eq-5D-5L
Measured: 5.25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start30 Dec 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Michael Kolinsky, Study chair, Cross Cancer Institute, Edmonton, Alberta, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439225
- Sponsor's protocol ID
- PR25
- Acronym
- OPTION-DDR
- Status last verified
- Apr 2026
- First submitted
- 27 May 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
- ClinicalTrials.gov ID
- NCT06439225
- Acronym / sponsor ID
- OPTION-DDR / PR25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 3 Jun 2024 (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.
The usual approach for most patients who are not in a study is treatment with docetaxel.
This study is being done to answer the following question: Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach?
This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach is defined as the care most people get for prostate cancer.
Detailed description
If taking part in this study, the patient will either get docetaxel, or carboplatin in addition to docetaxel. In both cases, the cancer will be monitored by CT scans and bone scans every 9 weeks, and blood tests every 3 weeks. Study treatments, scans, and tests will continue until the disease gets worse.
After finishing study treatment, even if treatment is stopped before the disease gets worse, the study doctor will continue to follow patients condition, watch for side effects and keep track of the health of the patient. If treatment is stopped before the disease got worse, patients will be asked to continue getting CT scans and bone scans every 9 weeks, and blood tests every 3 weeks, until the disease worsens. If the disease gets worse while receiving treatment, or after treatment is stopped, the patient will be contacted by phone every 3 months for the rest of their life to monitor their status. Patients may be seen more often if the study doctor thinks it is necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: Docetaxel |
| Carboplatin + Docetaxel | Experimental | Drug: Docetaxel, Drug: Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologic diagnosis of adenocarcinoma of the prostate. The presence of neuroendocrine or small cell carcinoma will be exclusionary
- Prior treatment with any ARPI, such as abiraterone, enzalutamide, apalutamide, or darotlutamide, is required.
- Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy, with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy, and have adequate washout as follows:
- Longest of one of the following:
- Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred
Key exclusion criteria (12 listed)
- Received prior platinum chemotherapy (i.e. carboplatin, cisplatin, oxaliplatin, satraplatin) or prior taxane chemotherapy (docetaxel, paclitaxel, cabazitaxel) at any time for the treatment of prostate cancer with the exception of docetaxel for mCSPCor adjuvant therapy after curative intent treatment for localized prostate cancer, as long as it was no more than 6 cycles and at least 12 months have elapsed from their last treatment to the date of enrollment. If the participant received prior platinum or taxane chemotherapy for other cancers, then please contact the CCTG office to discuss this further with the trial team.
- Active anticancer systemic therapy or investigational agents within 14 days of randomization.
- Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure (NYHA Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Participants with myelodysplastic syndrome/acute myeloid leukemia.
- Malignancy within the previous 2-years with a > 30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer, and in-situ or superficial bladder cancer.
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 |
|---|---|---|
| Docetaxel75mg/m2 q21 days | Drug | Carboplatin + Docetaxel, Docetaxel |
| CarboplatinAUC5 q21 days | Drug | Carboplatin + Docetaxel |
Primary outcome
Overall Survival
Time frame: 5.25 years
9 secondary outcomes
To compare the two treatment arms with respect to PSA response
Time frame: 5.25 years
To compare the two treatment arms with respect to progression free survival
Time frame: 5.25 years
To compare the two treatment arms with respect to time to next systemic therapy
Time frame: 5.25 years
To compare the two treatment arms with respect to time to number and severity of adverse events
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-P questionnaire
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by FACT-Taxane questionnaire
Time frame: 5.25 years
To compare the two treatment arms with respect to patient-reported Quality of Life (QoL) quantified by BPI-SF questionnaire
Time frame: 5.25 years
Economic Evaluation of healthcare utilization
Time frame: 5.25 years
Economic Evaluation of health utilities measured by Eq-5D-5L
Time frame: 5.25 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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Michael Kolinsky study chair
Cross Cancer Institute, Edmonton, Alberta, Canada
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and Carboplatin in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Prostate Cancer, run by Canadian Cancer Trials Group at 14 sites 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 24 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mariam Jafri (613-533-6430, mjafri@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 5.25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.